TAMPERE, Finland, Sept. 12, 2023 /PRNewswire/ -- Bioretec Ltd, a pioneering company dedicated to advancing biodegradable orthopedic implants, has signed a distribution agreement for the U.S. market with Spartan Medical Inc. The agreement covers Bioretec's innovative RemeOs™ screws, manufactured from a proprietary biodegradable metal alloy, which received market authorization from the U.S. Food and Drug Administration (FDA) in March 2023. The signed distribution agreement signals the commencement of the rollout of the RemeOs™ screws in the United States, the world's largest orthopedic market.
The agreement outlines the initiation of a controlled launch of the U.S. distribution of the RemeOsTM screws within strategically selected top-tier academic centers. Additionally, the distribution agreement involves a potential to penetrate into the extensive U.S. Department of Defense and the Veterans Administration healthcare market.
"Spartan Medical's view on the commercialization of new products in the orthopedic market perfectly aligns with Bioretec's vision for a controlled launch of RemeOs™ screws, which we believe is crucial in ensuring the widespread adoption and success of RemeOs™ screws in the times ahead. The path to choosing the distribution partnership in the United States was diligently assessed. Bioretec considered various options, ranging from collaboration with international industrial players to nationwide distribution partners, and even contemplated the possibility of engaging multiple local distributors. After weighing different options, the signed distribution agreement marks another step forward, and we are delighted to initiate our commercial collaboration with Spartan Medical, accompanied by first deliveries", comments Timo Lehtonen, CEO of Bioretec.
"When clinicians are seeking innovative, best-in-class medical technologies, I'm proud to say they come to us," says Vince Proffitt, President of Spartan Medical. "That's because we only distribute technologies, we know, that will improve patient outcomes and revolutionize the healthcare industry. Bioretec's innovative RemeOs™ screws are one of those technologies...simply put, a game changer for the industry."
Bioretec's commercialization strategy for the RemeOs™ screws also includes the involvement of local key opinion leaders, active participation of the company's Scientific Advisory Board, and utilizing comprehensive education and training platform within selected academic centers. With this strategic approach, the goal is to engage the surgeon communities and gather valuable post-market data for the expansion of the RemeOs™ product portfolio and to raise awareness about the clinical benefits of RemeOs™ screws.
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
Nordic Certified Adviser AB, +46 70 551 67 29
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, CE-mark is expected to be received during 2023. Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.
Spartan Medical in brief
Spartan Medical is a leading provider of innovative medical technologies and solutions for healthcare providers, government agencies, schools, civilian hospitals, and ambulatory surgery centers. Located near Washington, D.C., the company has been recognized as a "top priority vendor" for the Veterans Health Administration - America's largest integrated healthcare system. Spartan Medical has been awarded more than 700 federal government contracts, and it has served hundreds of private medical facilities and schools around the world. Spartan Medical's vast network and experience have made it an industry leader for any organization seeking to buy or sell innovative medical technologies and solutions.
Better healing – Better life. www.bioretec.com