Pharma Focus Asia

Sparta Biopharma Announces US Commercial Availability of BioEnthesis™ for Rotator Cuff Repair

Wednesday, March 10, 2021

Sparta Biopharma, Inc., a privately-held company, developing osteobiologics for sports medicine announces the availability of BioEnthesisTM, the first-of-its-kind allograft that has both mineralized and demineralized layers which provide the requisite properties for healing and repair within the rotator cuff.  According to the Healthcare Cost and Utilization Project, there are more than 4.5 million physician visits per year for rotator cuff pain and dysfunction.

Osteobiologics have been used successfully over the last several decades. These allografts have facilitated the formation of functional bone tissue and the healing of bone. In that time, hundreds of allograft compositions and forms have served patients across multiple orthopedic ailments. However, their potential to recreate and regenerate bone at the intersection of soft and hard-tissue had not been fully explored. Sparta has combined insights from biology, pharmaceutical sciences, and tissue engineering to develop BioEnthesis for the repair and reconstruction of bone within the rotator cuff enthesis.

Through a proprietary manufacturing process, Sparta developed BioEnthesis. It is a biphasic cancellous bone allograft that possesses structural characteristics and handling of a soft tissue allograft, with an intact porous collagenous matrix for soft tissue ingrowth and, a highly calcified layer to promote osseointegration. It serves as a scaffold to repair the bone of the enthesis and at the same time provides a strong foundation that facilitates tendon incorporation.

"Though modern arthroscopic techniques have significantly improved outcomes following rotator cuff repair, there are still unacceptably high levels of re-tear. The mode of failure is typically related to the tendon not healing adequately to the bone, which is anatomically referred to as the enthesis," said Adam Yanke, MD, PhD., Chair of the Scientific Advisory Board of Sparta Biopharma, and Assistant Professor at Midwest Orthopedics at Rush. "Approaches to improving the tendon to bone healing such as scaffolds and biologics are likely to improve these structural failure rates. BioEnthesis can be utilized in rotator cuff tear surgery to potentially reduce structural failures and I am excited to see the healing rates in clinical use."

"Since our founding, our approach to research and development has been guided by the needs of patients while working with surgeons to ensure seamless integration into their surgical setting," said Dushyanth Surakanti, Co-founder and CEO of Sparta Biopharma. "Incorporating our stakeholders' needs into everything we do result in a purpose-built solution. Co-founder and COO, Dimitrios Angelis added, "We are creating the right foundation to help improve the current standard of care.  We are looking forward to partnering with surgeons and outpatient surgery centers across the country and worldwide to help them deliver BioEnthesis to their patients."

magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024ISPE Singapore Affiliate Conference & Exhibition 2024Rehab Expo 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024