RESEARCH TRIANGLE PARK, N.C., June 28, 2022 (GLOBE NEWSWIRE) -- About five years ago, the U.S. Food and Drug Administration (FDA) announced plans to toughen its guidelines around the development and oversight of regenerative medicine products. The goal was to make sure these therapies – which are growing rapidly in numbers – are safe and effective for consumers, while also providing a framework to encourage innovation.
The changing regulatory landscape provided the impetus for Merakris Therapeutics to immediately engage with the FDA on its technology and the steps required to meet the new requirements, according to the Research-Triangle headquartered company’s CEO, Chris Broderick. Merakris was one of the first companies in its industry to do so.
Frequent communication with the agency helped Merakris – which specializes in cell-derived biotherapeutic technologies that promote healing of damaged tissue – to better understand what it needed to do to comply, Broderick said. During the process, the company shared its wound healing intellectual property with the FDA and discussed its proposed path forward.
“We provided information about the biological release assays we planned to develop to meet the agency’s new requirements,” Broderick explained. “And, through our discussions, we also helped regulators better understand and appreciate the value of our products and their benefit to patients.”
As a result, Merakris was one of the first regenerative medicine companies to get an Investigational New Drug (IND) application approved by the FDA, and one of the first to be cleared to begin clinical trials to support the safety and effectiveness of its therapies.
It’s this journey that Broderick will discuss at an upcoming expert panel discussion – “What Is Next for the FDA and the Wound Care Community” – that is part of the Advanced Wound Care Summit to be held in Boston, July 13-14. He will be joined by Dev Verma, medical officer at the FDA’s Center for Drug Evaluation and Research, and Vicki Driver, system chief at INOVA Wound Healing and Hyperbaric Medical Centers.
The Wound Care Summit is the first industry-led forum focused on delivering innovative wound care treatments to patients. It will feature a broad range of global leaders in wound care research who are driving the development of novel biomaterials, remote-monitoring devices, and digital health management solutions. The audience will include company executives, investors, researchers and other healthcare professionals.
“Merakris is delighted to be a part of this important conference,” Broderick said. “And I really look forward to joining distinguished panelists from the FDA and the wound care community to discuss the future direction of our industry.”
About Merakris
Merakris Therapeutics – founded in 2016 – pioneers the use of commercially scalable stem cell-derived biotherapeutics that promote the healing of damaged tissue. Its mission is to improve global patient care and outcomes through regenerative biotechnologies. The company’s products include:
- Dermacyte® Amniotic Wound Care Liquid, a cell-free amniotic injection that is being developed under Merakris’ IND for wound healing;
- Dermacyte® Matrix, a human amniotic membrane tissue graph that provides a protective covering for skin wounds and surgical sites; and
- Opticyte® Matrix, an ophthalmic barrier to the corneal surface of the eye and can be used with various ocular procedures.
Merakris also is investigating other novel biotechnology solutions that promote wound healing and skin rejuvenation.
