Bioventus Receives Authorization to Proceed Under Investigational New Drug Application for Clinical Trial of Placental Tissue Particulate (PTP-001) for the Treatment of Knee OA
DURHAM, NC – November 18, 2020 – Bioventus, a leader in Solutions For Innovative Healing, received authorization to proceed under its investigational new drug (IND) application from the US Food and Drug Administration (FDA), allowing it to proceed to clinical trials of PTP-001. PTP-001 (commercial trade name MOTYS™) is a placental tissue particulate comprised of amnion, chorion and umbilical cord from full-term, healthy births and is provided sterile in micronized form.
Bioventus plans to evaluate the safety and efficacy of PTP-001 to treat osteoarthritis of the knee through an open-label, dose-escalation study. The study is expected to enroll 20 patients, 40-80 years of age and test two doses (low and high dose) of PTP-001 in two unique cohorts of 10 patients each. Each patient will receive a single injection of PTP-001.
“This submission and open IND for PTP-001, the first for Bioventus, is a monumental milestone in the history of our young company. We are proud of our submission team and are ready to begin enrolling patients and administering PTP-001 in Phase 1 of our study,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus.
“This study will assess clinical safety of two doses of PTP-001, both at or higher than those often utilized today by physicians. Our goals are to begin to clarify the potential dose for PTP-001 and to determine whether PTP-001 could fulfill an unmet need for physicians and their patients with knee osteoarthritis,” she added.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations For Active Healing from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com and follow the company on LinkedIn and Twitter.
Media Contact: Thomas Hill, , [email protected]
Bioventus and the Bioventus logo are registered trademarks and MOTYS is a trademark of Bioventus LLC.
Bioventus Appoints Chris Yamamoto Senior Vice President of Business Development and Strategy
DURHAM, NC – November 16, 2020 – Bioventus, a global leader in Innovations For Active Healing, has appointed Chris Yamamoto as Senior Vice President of Business Development and Strategy. Yamamoto brings nearly 20 years of experience in mergers & acquisitions and business development. He will be responsible for developing an inorganic growth strategy for the company and executing deals that will drive long-term value and further the company’s mission of helping patients regain active lifestyles. Yamamoto will report to Bioventus CEO, Ken Reali and will join the company’s executive leadership team.
“Chris is coming on board at an exciting time at Bioventus as we seek to accelerate growth and build scale and depth in our offerings through both organic and inorganic investment,” said Reali. “We are pleased to welcome Chris to the team. He is a highly respected leader in the global M&A community and I am confident he will make significant contributions to our ongoing success as we execute our growth and value creation strategy.”
Yamamoto joins Bioventus from Becton Dickinson and Company where he spent the last six years, most recently as Vice President and Managing Director of Corporate Development. Prior to Becton Dickinson, Yamamoto was a Vice President with The Blackstone Group. He also worked at Fox Paine, Thoma Cressey, UBS Investment Bank and other institutions. Yamamoto received a Bachelor of Arts in Economics cum laude from Williams College.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations For Active Healing from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com and follow the company on LinkedIn and Twitter.
Media Contact: Thomas Hill, , [email protected]
Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
Bioventus to Provide CVS Caremark with its Portfolio of Preferred Options for Knee Osteoarthritis Patients Seeking Pain Relief
DURHAM, NC – November 10 – Beginning January 1, 2021 Bioventus, a global leader in Innovations For Active Healing, will gain preferred access through the CVS Caremark Formulary, to DUROLANE®, GELSYN-3® and SUPARTZ FX®, for the treatment of knee osteoarthritis (OA) pain. CVS Caremark manages the drug benefits for more than 40 million lives, which includes the prescription drug benefits of 6 million Aetna members.
DUROLANE, is a single-injection, GELSYN-3, a three-injection, and SUPARTZ FX, a five-injection hyaluronic acid (HA)-based joint-fluid treatment for patients. All three products will be among the four preferred standard formulary options of knee OA treatments for CVS Caremark members.
“CVS Caremark members now have access to the broadest HA portfolio available to patients and physicians in the US,” said John Nosenzo, Chief Commercial Officer, Bioventus. “DUROLANE, GELSYN-3 and SUPARTZ FX, all from Bioventus, provide long lasting OA knee pain relief allowing patients to resume more active lives.”
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations For Active Healing from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com and follow the company on LinkedIn and Twitter.
More information about the entire Bioventus portfolio of HA-based products is found at www.OAKneePainRelief.com.
Media Contact: Thomas Hill, , [email protected]
Bioventus, the Bioventus logo, GELSYN-3 and DUROLANE are registered trademarks of Bioventus LLC. SUPARTZ FX is a registered trademark of Seikagaku Corp. CVS Caremark is a registered trademark of CVS Pharmacy, Inc.
Summary of Indications for Use:
DUROLANE is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen. Do not inject DUROLANE in patients with knee joint infections, skin diseases, or other infections in the area of the injection site. Do not administer to patients with known hypersensitivity or allergy to sodium hyaluronate preparations. Risks can include transient pain or swelling at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Full prescribing information can be found in package insert, at www.DUROLANE.com, or by contacting Bioventus Customer Service at 1-800-836-4080.
GELSYN-3 is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g. acetaminophen). Do not administer to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations. Do not inject GELSYN-3 into the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site. GELSYN-3 is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.GELSYN3.com or by contacting customer service at 1-800-836-4080.
SUPARTZ FX is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies to avian (bird) products (feathers and eggs). SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site. Full prescribing information can be found in product labeling, at www.SupartzFX.com or by contacting customer service at 1-800-836-4080.
