Altimmune Announces Manufacturing Agreement with Vigene Biosciences for AdCOVID™, its Single Dose Intranasal Vaccine Candidate for COVID-19

GAITHERSBURG, Md., July 22, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the Company has entered into an agreement with Vigene Biosciences (“Vigene”) to manufacture AdCOVIDTM, Altimmune’s single-dose intranasal vaccine candidate for COVID-19. Vigene, a Rockville, Maryland-based award-winning Contract Development and Manufacturing Organization (CDMO), specializes in viral vectors and will deploy its capabilities to manufacture AdCOVID. Following recent positive pre-clinical data, Altimmune plans to start a Phase 1 clinical trial of AdCOVID in Q4 2020.

“Vigene is a fantastic partner to advance AdCOVID into Phase 1 clinical testing and beyond,” said Dr. Vipin K. Garg, President and CEO of Altimmune. Dr. Garg continued, “We believe Vigene’s deep experience in viral vector production and their collaborative, client focused approach will help facilitate Altimmune’s timeline for clinical development of AdCOVID.”

“With our new state-of-the-art manufacturing facility and our expertise in viral vector production, we are well positioned to support Altimmune in their COVID-19 vaccine development efforts,” said Dr. Zairen Sun, Vigene’s President and CEO. “In addition to our existing facility, we are in the process of expanding our capacity so that we can support Altimmune beyond clinical development into commercial scale manufacturing.”

Altimmune is also initiating scale up of manufacturing of its AdCOVID vaccine for advanced clinical trials and commercial production. The Company is actively engaged in discussions with additional strategic manufacturing partners with the goal of producing at least 100 million doses of AdCOVID in 2021.

AdCOVID is an intranasal vaccine candidate designed to block viral infection and to provide protection against viral spread through stimulation of both mucosal and systemic neutralizing antibodies (IgA and IgG) as well as cell-mediated immunity. By stimulating mucosal immunity in the nasal cavity, a key point of entry and replication for SARS-CoV-2, AdCOVID has the potential to defend against both infection in the recipient as well as spread of the virus to others. Intranasal administration can also be accomplished more simply than an injection and may eliminate the need for highly trained medical personnel. In addition, since it is expected to have extended stability at room temperature, AdCOVID may avoid the need for costly cold chain logistics.

In preclinical studies conducted in collaboration with the University of Alabama at Birmingham (UAB), AdCOVID stimulated both strong serum neutralizing activity and potent mucosal immunity (IgA) in the respiratory tract. Additionally, vaccination of mice with AdCOVID caused the rapid recruitment of immune cells into the respiratory tract, draining lymph nodes and spleen consistent with induction of potent local and systemic immunity. Increases in CD8+ and CD4+ T cells, dendritic cells and NK cells were observed in the respiratory tract, and germinal center and memory B cells as well as T follicular helper cells were observed in regional lymph nodes and the spleen. Importantly, the latter cell types have been associated in prior vaccine development research with long-lived antibody responses.

About Vigene Biosciences
Vigene Biosciences, Inc. is an award-winning leader in viral vector-based gene delivery for both life science research, gene therapy and cell therapy purposes. Headquartered in Rockville, Maryland, Vigene features 10 fully equipped GMP clean room suites for AAV, lentivirus, retrovirus, adenovirus and plasmids GMP production, respectively.  In addition, Vigene also develops and owns a panel of intellectual properties including proprietary high productivity cell lines (suspension and adherent cells) for viral vector packaging and patents for increasing viral vector packaging efficiency.  Vigene offers FDA and EMA compliant cGMP production for viral vector and plasmid production with the mission of making gene therapy affordable.  For more information on Vigene, please visit www.vigenebio.com.

About Altimmune
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating treatment for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.

Forward-Looking Statement Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the initiation and timing of the AdCOVID Phase 1 clinical trial in Q4 2020, the initial immunogenicity results of our AdCOVID preclinical studies,  the potential immunization effects of AdCOVID, our ability to manufacture 100 million doses of AdCOVID in 2021, and the prospects for regulatory approval, commercializing or selling AdCOVID or any of our other product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; the Company’s ability to secure manufacturing approval from its SARS-CoV-2 cell licensor on the timelines anticipated; the Company’s ability to secure additional manufacturing partners; the Company’s ability to obtain potential regulatory approvals on the timelines anticipated, or at all; and the Company’s ability to expand its pipeline of products and the success of future product advancements, including the success of future clinical trials, and the Company’s ability to manufacture and commercialize its products. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 and quarterly report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC, which are available at www.sec.gov.

Contacts          

Altimmune:    

Will Brown , Chief Financial Officer  

Phone: 240-654-1450  

Email: wbrown@altimmune.com

Vigene Biosciences:
Jeffrey Hung, Ph.D., Chief Commercial Officer
301-251-6638
jhung@vigenebio.com 

SMART Medical Systems Receives FDA Clearance for Its G-EYE® Colonoscope

SMART's G-EYE® Colonoscope, incorporating the G-EYE® Balloon Technology which helps control the endoscope's field of view and positioning during colonoscopy, was cleared for marketing in the USA by FDA

NEWS PROVIDED BY SMART Medical Systems Ltd. 

May 26, 2020, 07:00 ET

RA'ANANA, Israel, May 26, 2020 /PRNewswire/ -- SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced that the FDA issued 510(k) clearance for its flagship product, the G-EYE® Colonoscope.

The G-EYE® colonoscope is a standard colonoscope which SMART remanufactures by installing its proprietary G-EYE® balloon on the distal bending section of the colonoscope. During colonoscopy, the G-EYE® colonoscope is inserted in the standard technique, with the balloon deflated. Once the colon is intubated and prior to withdrawal, the balloon is inflated to engage the colon lumen. Withdrawal of the G-EYE® Colonoscope through the colon with the balloon moderately inflated centralizes the image of the colon lumen, flattens colonic folds, and reduces the amount of bowel slippage, thereby assisting in controlling the colonoscope's field of view and positioning. In published clinical studies comparing adenoma detection rate of G-EYE® colonoscopy to that of standard colonoscopy, G-EYE® colonoscopy demonstrated substantial increase in the detection of cancerous polyps which are the precursors of colon cancer (GIE 2019; 89: 545-553; and Endoscopy 2015; 47: 238–244).

Under the current FDA clearance, the G-EYE® colonoscope will be available based on selected 510(k) cleared colonoscopes of OLYMPUS (8 models) and PENTAX Medical (3 models). SMART is currently preparing its 510(k) submission for the FUJIFILM brand.

"We are excited to have the G-EYE® colonoscope available for American patients, doctors and endoscopy practices, and are proud of taking part in the global effort to provide advanced technologies for colonoscopy", said Brian Cochrane, CCO of SMART's US subsidiary. "We are now initiating our launch of the G-EYE® colonoscope in the US market, aiming to make it available to clinical collaborators and customers".  

"This FDA clearance is a cornerstone for our company", said Gadi Terliuc, SMART's CEO. "This important milestone, adding to our recently-formed strategic partnership with FUJIFILM, is part of our evolution as a meaningful provider of enabling endoscopy products".

About SMART Medical Systems

SMART Medical Systems is a pioneer in the development and manufacture of innovative medical devices in the field of gastro-intestinal (GI) endoscopy. SMART's unique approach is to use available brand name endoscopes and address key challenges in contemporary endoscopy. SMART's CE Marked and FDA cleared NaviAid™ product family is commercially distributed in key global markets. With its new partnership with FUJIFILM adding to its already existing alliance with PENTAX Medical, SMART's G-EYE® colonoscopy solution is currently adopted by two of the three industry leaders in GI endoscopy imaging. SMART is headquartered in Israel, and operates in the United States through its wholly-owned subsidiary, SMART GI Inc. For more information, please visit: www.smartmedsys.com/us/

Contacts:

Brian Cochrane - CCO
+1-201-661-3795
bcochrane@smartmedsys.com

Vigene Biosciences Opens State-Of-The-Art Headquarters in Rockville, MD

Major addition to Maryland’s biotech corridor with the mission to make gene therapy affordable

“The new headquarters firmly seals Vigene’s commitment to revolutionize gene and cell therapy while rooted in Montgomery County, Maryland, USA.”

ROCKVILLE, MD. (PRWEB) JANUARY 29, 2020 -- Vigene Biosciences, a pioneer in the viral gene delivery space, unveils its 71,000 square foot state-of-the-art global headquarters in Rockville, MD. The dedication of the 10 GMP suites including GMP viral vector suites and GMP plasmid suites across 3 campuses coincides with the announcement of a long-term strategic partnership with ASC Therapeutics, a California gene-therapy company.

An award-winning CDMO, Vigene’s mission is to make gene therapy affordable. It provides viral vector-based gene delivery services and products for research and clinical applications. It strives to achieve this vision by streamlining virus production from early conceptual stages to commercial manufacturing.

The new facility, custom-built for Vigene, combines new manufacturing technologies and high-yield production cell lines with the rigorous quality of cGMP and BSL-2. The new headquarters firmly seals Vigene’s commitment to revolutionize gene and cell therapy while rooted in Montgomery County, Maryland, USA.

Vigene is listed on Inc. 5000 fastest-growing private companies in America for 2019 and 2018, named the 2018 ACG Emerging Company of the Year, and is a finalist for Maryland Tech Council’s Emerging tech company of the year award 2019 and 2018. It is one of the few gene therapy CDMO companies in the world which offers research grade, pre-IND, IND, and commercial grade viral vectors and plasmid DNAs.

Among the VIP attendees at the dedication: Ben Wu, CEO, Montgomery County Economic Development Corporation, Gina Hann, President of Batten Hope Foundation, and Dr. Suk See DeRavin, a gene therapy leader from NIH. Quotes and photos from the dedication are available.

About Vigene Biosciences:

Vigene Biosciences, Inc is a leader in viral vector based gene delivery for both life science research, gene therapy and cell therapy purposes. Headquartered in Rockville, Maryland, Vigene offers plasmid, AAV, lentivirus, retrovirus and adenovirus based products and custom services. Vigene’s mission is to make gene therapy affordable. Vigene offers IND-enabling and IND-supporting materials as well as FDA- and EMA-compliant commercial products for plasmid, AAV, lentivirus, retrovirus and adenovirus with proven technologies and track records. To learn more about Vigene Biosciences, please visit http://www.vigenebio.com

TELA Bio Announces Closing of Initial Public Offering of Common Stock

MALVERN, Pa., Nov. 13, 2019 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (“TELA”) (Nasdaq: TELA), a commercial stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today announced the closing of its initial public offering of 4,000,000 shares of common stock at a public offering price of $13.00 per share. Aggregate gross proceeds to TELA were approximately $52.0 million, before underwriting discounts, commissions and other offering expenses.  All shares of common stock were sold by TELA.  TELA’s common stock is listed on The Nasdaq Global Market under the symbol “TELA.” TELA has granted the underwriters a 30-day option to purchase up to 600,000 additional shares of common stock at the initial public offering price, less underwriting discounts and commissions.  

Jefferies LLC and Piper Jaffray & Co. acted as joint book-running managers for the offering. Canaccord Genuity LLC acted as lead manager and JMP Securities LLC acted as co-manager.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission (SEC) on November 7, 2019.  This offering was made only by means of a prospectus.  A copy of the final prospectus relating to the offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-547-6340 or by email at Prospectus_Department@Jefferies.com, and from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by email at prospectus@pjc.com or by phone: 1-800-747-3924.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

About TELA Bio, Inc.

TELA Bio, Inc. is a commercial stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction. TELA’s products are designed to improve on shortcomings of existing biologics and minimize long-term exposure to permanent synthetic material. TELA's portfolio is supported by quality, data-driven science and extensive pre-clinical research that has consistently demonstrated advantages over other commercially available products.

Caution Regarding Forward-Looking Statements

This press release may contain forward-looking statements regarding TELA’s current expectations. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. These and other risks and uncertainties are described more fully in the section captioned “Risk Factors” in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and TELA undertakes no duty to update such information except as required under applicable law.

TELA Bio Contact
Stuart Henderson

Vice President, Corporate Development and Investor Relations
TELA Bio, Inc.
484-320-2930
shenderson@telabio.com

Investor Contact
Peter Vozzo
Westwicke
443-213-0505
peter.vozzo@westwicke.com

RK Pharma Inc. Secures Significant Investment in New Round of Growth Capital Financing from Signet Healthcare Partners

RK Pharma Inc. Secures Significant Investment in New Round of Growth Capital Financing from Signet Healthcare Partners

Pearl River, NY (August 5, 2019) – RK Pharma Inc. (“RK”, or “RK Pharma”, or “the Company”), a privately-owned fully vertically integrated generic pharmaceutical company, with participation across the value chain from intermediates, active pharmaceutical ingredients (“API”) and drug product manufacturing, announced today that on August 5, 2019 it completed a financing transaction which will help fund its next stage of expansion. The investment was made by Signet Healthcare Partners (“Signet”), a New York based growth equity firm specializing in healthcare investments.

Concurrently, James Gale, Managing Director at Signet Healthcare Partners, will join the board of directors of RK Pharma. The growth capital will be used to enhance RK Pharma’s manufacturing capabilities at the Pearl River site and its research and development investments in expanding the company’s diverse pipeline of generic products.

Dr Ravishanker Kovi, Founder & Executive Chairman of RK Pharma Inc said, "We had an excellent working relationship with Signet in our earlier venture and are very excited at the opportunity to partner with Signet again. The current investment will allow us to accelerate the growth of our vertically integrated business and add capacity to our Pearl River, New York, injectables manufacturing facility. The new facility and equipment will allow us to innovate and introduce our Ready to Use/ Ready to Dilute Injectables, Prefilled Syringes, Vials, IV Bags, Sterile Ophthalmic medications, and other sterile high potent drug products to the market”.

In addition to the Manufacturing facility in New York, the RK Pharma group of companies include Apicore LLC, Archis Pharma LLC (both 100% subsidiaries) and significant stake in Aktinos Pharma Pvt Ltd. Apicore and Aktinos provide a rich supply of complex API’s and Intermediates. Archis Pharma is the commercialization arm of the RK Pharma Group. The company is evaluating several in-licensing opportunities of marketed products in addition to launching its own products.

“We are pleased to collaborate again with Dr. Kovi to develop complex APIs and injectable drugs. We share his commitment to improving patient access to more affordable medications,” said James Gale, Managing Director at Signet Healthcare Partners. “Signet is very excited to be partnering with this talented group of individuals. ”

Pepper Hamilton LLP acted as legal counsel for Signet Healthcare Partners and Sheppard, Mullin, Richter & Hampton LLP acted as legal counsel for RK Pharma.

About RK Pharma

RK Pharma is a New Jersey based privately held Company that was founded in 2018. The Company has a focus on the development, manufacture and sale of high quality and affordable generic pharmaceutical products worldwide. RK Pharma has a unique integrated development, regulatory and manufacturing capabilities, with a focus on products with formulation challenges and first generic opportunities.

About Signet Healthcare Partners

Signet Healthcare Partners is an established provider of growth capital to innovative healthcare companies. Signet invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm’s focus has primarily been on the pharmaceutical sector and medical technology companies. Signet maintains a disciplined, yet flexible investment approach. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet’s 18-year history, it has developed a strong reputation and track record of successful investments. Signet has raised four funds with total capital commitments of over $400 million and has invested in more than 45 companies. For more information, visit www.signethealthcarepartners.com.

For more information, please contact:

RK Pharma:

George R. Thomas, Ph.D., MBA

President & CEO

732-640-4351

george@rkpharmainc.com

Signet Healthcare Partners:

Jerry Liao

Senior Associate

212-893-1179

jerry.liao@signethp.com

CoreRx, Inc. Announces Commercial Supply Agreement for Aimmune Therapeutics’ Investigational Peanut Allergy Treatment

CLEARWATER, FL, USA, May 14, 2019 /EINPresswire.com/ -- CoreRx, Inc. Announces Commercial Supply Agreement for Aimmune Therapeutics’ Investigational Peanut Allergy Treatment

Clearwater, Florida, May 14, 2019 — CoreRx, Inc. today announced that it has executed a commercial supply agreement with Aimmune Therapeutics, Inc., for the commercial manufacture of AR101, an investigational treatment for peanut allergy currently under review for potential approval by the U.S. Food and Drug Administration. CoreRx has been the development manufacturer of AR101 through multiple successful phase 2 and phase 3 clinical trials of the drug. 

Todd R. Daviau, President and CEO of CoreRx stated: “Aimmune has long been an important client-partner of CoreRx, and we're pleased to build on that relationship with this agreement as the company prepares for the potential commercial launch of AR101. We’re proud to be part of the team working to make the potential first treatment for peanut allergy available to the millions of children at risk of having allergic reactions to peanut. This agreement positions CoreRx to meet the anticipated strong demand for AR101, both in the United States and globally, for the next several years. This agreement is also a significant milestone for CoreRx, providing the opportunity to showcase the capabilities of our world-class organization in a major emerging therapeutic space, and we expect to follow it with additional strategic manufacturing arrangements with other CoreRx clients.”

AR101 is being developed as a treatment to reduce the risk of anaphylaxis following accidental exposures to peanut. Aimmune began phase 2 clinical trials of AR101 in early 2014, followed by phase 3 clinical trials in early 2016. The AR101 commercial manufacturing facility, located on the CoreRx campus, includes state-of-the-art air-handling systems and equipment to prevent cross contamination of allergens, along with controls and management systems to ensure safety and compliance with U.S. and European pharmaceutical manufacturing regulations. It can manufacture approximately 189 million dosage units of AR101 per year. 

“CoreRx shares Aimmune’s commitment to improving the lives of people with food allergies and has been a great partner through the complex operation of supplying multiple different doses of AR101 for our clinical trials on a timely basis,” said William Turner, Aimmune’s Senior Vice President, Technical Operations and Regulatory Science. “We’re pleased to have their experience and expertise on board as we prepare for commercial launch of what could be the first treatment for peanut allergy, as we have seen them become a key contributor to the rapidly growing life science and biotechnology industry in the central Florida area.”

About CoreRx, Inc.
CoreRx is a Contract Development Manufacturing Organization (CDMO) with capabilities to support clinical – niche commercial manufacturing, offering state of the art facilities to support your supply chain needs. Our integrated offerings provide comprehensive services for the development, manufacturing, and testing of solid, liquid and semi-solid dosage forms.

Keep on top of new developments at CoreRx and throughout the drug development industry by following www.linkedin.com/company/corerx-inc. To get more detailed information about the company, visit www.corerxpharma.com.

Mark DaFonseca, Chief Business Officer
CoreRx, Inc.
+1 727-259-6950

Vigene Biosciences Secures Institutional Investment in New Round of Growth Capital Financing

ROCKVILLE, Md., April 29, 2019 /PRNewswire/ -- Vigene Biosciences, Inc ("Vigene") a leading provider of viral vector products and services used in gene therapy, has completed a substantial growth capital financing transaction.  The investment was made by Signet Healthcare Partners ("Signet"), a New York based growth equity firm specializing in healthcare investments.

The growth capital will be used to support Vigene's expansion into a new facility to support the growing demand for viral vector and plasmid production in the rapidly expanding fields of cell and gene therapy.  Construction of the new facility, located in Rockville, Maryland, is set to be completed mid-2019 and will increase Vigene's office, laboratory and cGMP production space by 51,000 sq. ft. The most notable additions from the expansion are 5 state-of-the-art cGMP viral manufacturing suites, which will increase Vigene's cGMP production facilities to 10 suites with over 30,000 sq. ft. of cGMP space.   

Vigene CEO Dr. Zairen Sun said, "We are very excited to receive this investment, which will allow us to accelerate the growth of our business. Signet Healthcare Partners is an ideal partner in further developing Vigene as a leader in the Contract Development and Manufacturing Organization (CDMO) space for viral vector cGMP production. The new facility and equipment will allow us to innovate and meet production demands as the fields of gene and cell therapy continue to advance."

Concurrently with the financing, Ashley Friedman, Managing Director at Signet Healthcare Partners, will join the board of directors at Vigene. "I believe the company is well positioned to capitalize on the rapidly evolving field of gene therapy. Signet looks forward to a close collaboration with Dr. Sun and the leadership team at Vigene," said Ashley Friedman.  Additionally, Jeffrey M Ostrove, Ph.D. will be joining Vigene as an Independent member of the board of directors.  Dr. Ostrove is a biotechnology executive with extensive experience in gene therapy, both on the drug development and CDMO side of the business.  Dr. Ostrove is currently the CEO of Locana Inc. "There is a great need for additional contract manufacturing and support services in the fields of cell and gene therapy as the FDA predicts there will be over 200 Investigational New Drug applications filed over the next 2 years which represents a substantial expansion of the field and Vigene is poised to support that effort," stated Dr. Ostrove.

Shulman Rogers Gandal Pordy & Ecker, P.A., acted as legal counsel for Vigene and Sheppard, Mullin, Richter & Hampton LLP acted as legal counsel for Signet Healthcare Partners.

About Vigene Biosciences

Founded in 2012, Vigene Biosciences is an award-winning leader in viral vector-based gene delivery for both life science research and gene therapy applications with the mission to make gene therapy affordable. Vigene offers cGMP as well as research-grade production of plasmid, AAV, lentivirus, adenovirus, and other viruses with proven technologies that comply with FDA and EMA guidelines. In 2018, Vigene ranked 81st on the Inc. 5000 list and was named the ACG Emerging Company of the Year. For more information, visit https://vigenebio.com/.

About Signet Healthcare Partners

Signet Healthcare Partners ("Signet") is an established provider of growth capital to innovative healthcare companies. Signet invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm's focus has primarily been on the pharmaceutical sector and medical technology companies. Signet maintains a disciplined, yet flexible investment approach. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 18-year history, it has developed a strong reputation and track record of successful investments. Signet has raised four funds with total capital commitments of over $400 million and has invested in more than 45 companies. For more information, visit www.signethealthcarepartners.com.

For more information please contact:

Vigene Biosciences
Jeffrey Hung, Ph.D.
Chief Commercial Officer
Vigene Biosciences
301-251-6638
jhung@vigenebio.com

Signet Healthcare Partners
Jerry Liao
212-893-1179
jerry.liao@signethp.com

SOURCE Vigene Biosciences

Goodwin Biotechnology Secures Significant Institutional Investment in New Round of Growth Capital Financing

FORT LAUDERDALE, Fla., April 22, 2019 /PRNewswire/ -- Goodwin Biotechnology, Inc. ("Goodwin") announced that it has completed its largest ever round of financing with growth capital which will help fund its next stage of expansion.  Goodwin is a full GMP, FDA-registered biopharmaceuticals Contract Development and Manufacturing Organization (CDMO) that offers a fully integrated Single Source Solution™ from Cell Line Development, Process Development including Bioconjugation, Scale-Up, cGMP Contract Manufacturing and Aseptic Fill/Finish of mammalian cell-culture derived life-saving monoclonal antibodies, recombinant proteins, vaccines, and Antibody Drug Conjugates (ADCs). The investment was made by Signet Healthcare Partners ("Signet"), a New York based growth equity firm specializing in healthcare investments.

Concurrently, Nikhil Puri and Jerry Liao, investors at Signet, will join the board of directors of Goodwin Biotechnology. The growth capital will be used to support Goodwin's investments in doubling its space available for cGMP capacity as it readies for further expansion of its biopharmaceutical manufacturing, including support for commercial product manufacturing and developing various capabilities to better serve its growing customer base. 

Goodwin's Chief Executive Officer Karl Pinto said, "Since the early 1990s, Goodwin has served its clients in bringing their products through the clinic with our unmatched service, flexibility and quality. We are now at a point where the opportunity to grow and support our clients transcends the clinic and takes them into commercial manufacturing. Our efficient size, experience and breadth of capabilities position us very strongly to serve in particular, cutting edge 'new biologics' products requiring small-to-mid volumes, to progress from the clinic and into the market, often within today's shortened and abbreviated clinical pathways. We thank our loyal clients, employees, advisors and investors for helping us get here, and we welcome the Signet team to the Goodwin family. My management team and I look forward to working with them to scale our business as our clients and the market demand us to, and ultimately help patients with some of the newest medical technologies being developed." 

Signet Healthcare Partners Managing Director Nikhil Puri said "Goodwin has established leading vertically integrated capabilities in process development and clinical manufacturing of complex large molecules, evidenced by projects consummated with more than 100 clients.  A substantial portion of new drug development pipeline are biologically derived, and I believe Goodwin is well positioned to serve biotech and pharma companies developing such products.  Signet is very pleased to be partnering with the Company at this important inflection point, and we look forward to close collaboration with Karl and his leadership team at Goodwin."

Fairmount Partners LP served as financial advisor for Goodwin. Pepper Hamilton LLP acted as legal counsel for Goodwin and Sheppard, Mullin, Richter & Hampton LLP acted as legal counsel for Signet Healthcare Partners.

About Goodwin Biotechnology, Inc.

Goodwin Biotechnology is a uniquely qualified and flexible, US-based CDMO that offers a Single Source Solution™ for our clients from cell line development, exploratory proof-of-concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and Biologic Drug Conjugates including Antibody Drug Conjugates (ADCs) for early- and late-stage clinical trials. By working with Goodwin Biotechnology, clients can enhance the value of their product candidates with clear development and manufacturing strategies, as well as a road map to meet the appropriate quality requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical development pathway in a cost-effective, timely, and cGMP compliant manner to enhance patients' lives. With over 26 years of experience as an independent integrated contract manufacturer, Goodwin Biotechnology has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multi-national biopharmaceutical companies. Based on the impressive track record, Goodwin Biotechnology has been awarded Frost & Sullivan's Customer Value and Leadership Award for Best Practices in Mammalian Contract Manufacturing!  In addition, Goodwin Biotechnology was awarded "Best in Sector: Biopharmaceutical Contract Development & Manufacturing" at Acquisition International magazine's 2015 Sector Performance Awards. Last year, Goodwin Biotechnology received Global Health & Pharma's 2017 award for Best for BioProcess Development & cGMP Manufacturing and Best in Mammalian Cell Culture Process Development & cGMP Manufacturing. In 2018, Goodwin Biotechnology was named Biologics cGMP Manufacturer of the Year 2018 by Global Health & Pharma News.  Click here to view the press releases!  Additional information may be found at http://www.GoodwinBio.com.

About Signet Healthcare Partners

Signet Healthcare Partners ("Signet") is an established provider of growth capital to innovative healthcare companies. Signet invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm's focus has primarily been on the pharmaceutical sector and medical technology companies. Signet maintains a disciplined, yet flexible investment approach. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 18-year history, it has developed a strong reputation and track record of successful investments. Signet has raised four funds with total capital commitments of over $400 million and has invested in more than 45 companies. For more information, visit www.signethealthcarepartners.com.

For more information please contact:

Goodwin Biotechnology 
SooYoung Lee, Ph.D.
Chief Operating Officer
954-327-9603
slee@GoodwinBio.com 
Or 
Info@GoodwinBio.com

Signet Healthcare Partners 
Jerry Liao
Senior Associate 
212-893-1179 
jerry.liao@signethp.com

SOURCE Goodwin Biotechnology, Inc.

TELA Bio® Announces 510(k) Clearance for Restella™ Reconstructive BioScaffolds for Reconstructive Surgery

Innovative product portfolio based on TELA Bio's proven technology platform advances the design of biologic-based materials for reconstructive surgery.

MALVERN, Pa., April 18, 2019 /PRNewswire/ -- TELA Bio®, Inc., a regenerative medicine company leading the development of advanced medical devices for soft tissue reconstruction, announced today that the company's Restella™ Reconstructive BioScaffolds have been awarded 510(k) clearance from the U.S. Food and Drug Administration for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive procedures. 

"We are excited to bring Restella Reconstructive BioScaffolds to U.S. surgeons and patients. These products were purposefully engineered to allow for rapid tissue integration and revascularization and biomechanical control," said Antony Koblish, president and chief executive officer of TELA Bio. "Specifically designed for use in reconstructive surgery, Restella products leverage the strong clinical experience of our OviTex® Reinforced BioScaffolds that have now been implanted in more than 4,500 patients."

The TELA Bio technology platform is based on interwoven polymer through layers of biologic tissue in a patented "lockstitch" pattern that creates a unique embroidered construction. The biologic material, derived from ovine rumen, is optimized to reduce foreign body response, minimize inflammation, and enable functional tissue remodeling. The interwoven polymer helps provide support along with improved handling and load-sharing capability.   

While biologic materials are often used for soft tissue reinforcement in reconstructive surgery, many surgeons report that currently available materials are costly and may stretch over time leading to patient dissatisfaction. Restella Reconstructive BioScaffolds are tailored to be highly permeable with controlled stretch to support a variety of surgical techniques and procedures. TELA Bio plans to offer resorbable and permanent polymer versions in the Restella Reconstructive BioScaffolds portfolio that will include a range of sizes and shapes.       

"Our success in applying the advantages of our technology platform to develop Restella Reconstructive BioScaffolds is another example of TELA Bio's unique ability to bring innovation and cost savings to address a wide range of needs in surgery," said Mr. Koblish, adding, "By expanding our platform to more surgeons and patients, we are bringing the same level of innovation and cost savings to the reconstructive surgery market that we have delivered with OviTex Reinforced BioScaffolds in hernia repair procedures."

About Restella Reconstructive BioScaffolds

Restella Reconstructive BioScaffolds are intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Bench and animal testing may not be indicative of clinical performance.

Caution: Federal (US) law restricts this device to sale by or on order of a physician.

About TELA Bio, Inc.

TELA Bio, Inc. is a disruptive regenerative medicine company focused on making advanced medical devices accessible to patients requiring soft tissue reconstruction. The company's products are designed to improve on shortcomings of existing biologics and minimize long-term exposure to permanent synthetic material. TELA Bio's portfolio is supported by high-quality, data-driven science and extensive pre-clinical research that has consistently demonstrated advantages over commercially available products. The company's OviTex Reinforced BioScaffolds for hernia repairs and abdominal wall reconstructions are commercially available in the U.S. and in Europe, and Restella Reconstructive BioScaffolds for reconstructive surgery are commercially available in the U.S. The company is collaborating with leading surgeons to drive rapid product development and establish TELA Bio as a leader in soft tissue reconstruction. To learn more about TELA Bio visit http://www.telabio.com.

Investor relations contact
Stuart Henderson
TELA Bio, Inc
484-320-2933
shenderson@telabio.com

Media contact
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

SOURCE TELA Bio, Inc.

RoundTable Healthcare Partners and Signet Healthcare Partners Establish New Platform in the Global Consumer Healthcare Market

Advantice Health Becomes a Global Consumer Healthcare Company with Category Leading Brands

LAKE FOREST, Ill., April 1, 2019 /PRNewswire/ -- RoundTable Healthcare Partners ("RoundTable"), an operating-oriented private equity firm focused exclusively on the healthcare industry, and Signet Healthcare Partners ("Signet"), an established provider of growth capital to innovative healthcare companies, announced today that they have established a new global consumer healthcare platform focused on over-the-counter ("OTC") pharmaceuticals.  The new platform company, Advantice Health, consists of the category-leading brands recently acquired from Moberg Pharma AB ("Moberg").  The brands Kerasal®, Kerasal Nail®, New Skin®, Dermoplast®, Domeboro®, Emtrix®, and Zanmira® fall into the footcare and first-aid OTC categories.

Advantice Health is the eighth company in RoundTable's current portfolio, joining three other companies participating in the consumer healthcare marketplace.  "RoundTable's fourth platform investment in the consumer healthcare market represents a highly strategic opportunity for us," said Thomas P. Kapfer, Senior Operating Partner and Chairman of the Board of Advantice Health.  "OTC pharmaceuticals are poised for considerable growth as consumers take more responsibility and make decisions for their own healthcare."

Mr. Kapfer continued, "Our newly-acquired brands provide an excellent foundation for us to build upon. We see a clear opportunity to build the Advantice product portfolio in OTC therapeutic skin care.  Our work in prescription-based dermatology products and high-end cosmetic skin care provides us with the experience and expertise needed to add value to this business.  This value creation orientation has been a long-standing strategic requirement for us."

RoundTable also announced the appointment of Timothy J. Connors to the position of Chief Executive Officer of Advantice Health.  Tim has over 30 years of experience in consumer healthcare and has held senior leadership positions in sales, marketing, new product development, and strategic planning.

"We are pleased to welcome Tim to Advantice Health and to RoundTable," said Mr. Kapfer.  "Tim is an outstanding leader who has a wealth of experience, expertise, and insight with a consistent track record of success. His appointment is a key element of our ongoing strategy to complement the management teams of our portfolio companies with world-class talent to accelerate their prospects for growth."

"I am excited to join the RoundTable family of companies and lead the Advantice Health team," said Mr. Connors.  "Our newly acquired group of brands, with leading category positions, is a solid foundation for future growth.  The company has a strong team of people and strategic partners that have created a successful business upon which we will build.  We plan to invest in growing the category and our market share through innovative marketing, exciting new products, and acquisitions.  RoundTable's unique operating orientation, transaction expertise, and commitment to the business will allow us to focus relentlessly on providing consumers with what they need, want, and value."

Advantice Health is the sixth investment from RoundTable's Equity Fund IV.  Signet joined RoundTable as an investor in Advantice Health.  As part of the transaction and to finance further growth opportunities for the company, RoundTable facilitated the completion of new senior credit facilities and a private placement of senior subordinated notes.  The senior credit facilities were led by Capital One, National Association and included CIBC Bank USA and Madison Capital  Funding LLC while the senior subordinated notes were provided by RoundTable Healthcare Capital Partners III, RoundTable's third captive subordinated debt fund.  Sidley Austin LLP acted as legal advisor to RoundTable in this transaction.

ABOUT ROUNDTABLE HEALTHCARE PARTNERS
RoundTable Healthcare Partners, based in Lake Forest, IL, is an operating-oriented private equity firm focused exclusively on the healthcare industry. RoundTable partners with companies that can benefit from its extensive industry relationships and proven operating and transaction expertise. RoundTable has established a successful track record of working with owner/founders, family companies, management teams, entrepreneurs and corporate partners who share a vision and believe in the value creation potential of its partnership model. RoundTable has raised $2.75 billion in committed capital, including four equity funds totaling $2.15 billion and three subordinated debt funds totaling $600 million. More information about RoundTable Healthcare Partners can be found at www.roundtablehp.com.

ABOUT SIGNET HEALTHCARE PARTNERS
Signet Healthcare Partners is an established provider of growth capital to innovative healthcare companies. Signet invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm's focus has primarily been on the pharmaceutical sector and medical technology companies. Signet maintains a disciplined, yet flexible investment approach. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 18-year history, it has developed a strong reputation and track record of successful investments. Signet has raised four funds with total capital commitments of over USD 400 million and has invested in more than 45 companies. More information about Signet Healthcare Partners can be found at www.signethealthcarepartners.com.