OrthoPreserve is developing a minimally invasive meniscus implant to relieve pain, restore mobility, and reduce the risk of knee joint arthritis for patients.
Over 1 million people in the United States every year receive surgical treatment for meniscus injuries due to their painful and debilitating symptoms. Most meniscus tears are treated with a meniscectomy (removal of the damaged tissue) since the meniscus has extremely limited healing capabilities. The removal of tissue increases the forces exerted on the knee joint cartilage, which can create recurring pain, mechanical impairment/immobility, and degenerative changes much earlier than if the meniscus was intact and protecting the cartilage. This forces a patient to undergo years of pain medication, injections, or physical therapy treatments to manage pain, which is costly and burdensome. Once the pain becomes severe enough and arthritis develops in the knee joint, patients must undergo a knee replacement surgery to relieve symptoms. There is a significant treatment gap between a meniscus injury and knee replacement that could be filled with an alternative treatment option such as a meniscus replacement. OrthoPreserve's meniscus replacement implant restores the cushioning properties of the natural meniscus to relieve pain and protect the knee joint from arthritis. It's novel fiber-reinforced hydrogel design mimics the structure and function of the natural meniscus to return the knee joint to a normal state and allows patients to return to activity symptom-free after a simple, minimally invasive surgery. The restoration of the knee joint mechanics also preserves the joint, mitigating the risk of arthritis and the need for a knee replacement in the future.
- Jonathan Schwartz, CEO, invented the implant while in graduate school at Georgia Tech. He gained 9 years of research, project management, and operations engineering experience before taking over the technology with OrthoPreserve.
- Dr. Cyrus Kump, CMO, brings 25 years of orthopedic surgery experience and a trailblazing attitude in treatment of his patients.
- Max Guillot, VP, has 6 years of experience in orthopedics and trauma and interfaces with hundreds of patients per month with a deep understanding of surgeon and patient needs.
- Brendan Baggot, VP Regulatory Affairs, brings 15 years of regulatory and clinical research experience. The team is also supported by an advisory board that has brought a collective 9 medical startups to exits.
- The team has all the components necessary to bring the meniscus implant to market and drive adoption including engineering, regulatory/clinical, and commercialization expertise.
After completion of the preclinical testing in the current phase of development, clinical trials will be executed for approximately 2 years. We will partner with our affiliated practices and hospitals, as well as additional clinical sites around the country to complete these trials. Once clinical trials are complete, we will apply for FDA approval by 2029, and solicit partnerships or an acquisition with leading orthopedic device companies at that time to leverage their sales/distribution networks and expertise. If not acquired upon FDA approval, we expect to execute a limited commercial launch using commission-based industry representatives with prior expertise in the field. These reps will represent OrthoPreserve at industry conferences and exploit their network of contacts to drive initial sales, build a database of prospects, distribute product information, etc. Over time, as our customer base and revenue grows, we plan to takes sales in house and create a small dedicated sales team to maximize OrthoPreserve market share and manage larger accounts with strategic partners/distributors. Marketing efforts will initially be focused on developing relationships with surgeons who are Key Opinion Leaders (KOL). They will use empirical evidence through use in the field to publish findings in industry periodicals, and discuss their experience in using the product at conferences. We plan to utilize the resources of our team and their practices to assist in promotion of our product and recruitment of additional KOLs to advance quick adoption from surgeons across the country as we demonstrate superiority over current treatments.
OrthoPreserve will generate revenue through the sale of its meniscus implant to hospitals, surgical centers, and orthopedic practices. The implants will be sold directly or through a distributor network, targeting orthopedic surgeons and sports medicine specialists as key decision-makers. Revenue will be primarily driven by procedures performed on patients experiencing pain after initial meniscus surgery. We will initially focus on securing insurance coverage under existing joint preservation and arthroscopy-related reimbursement codes. As the implant gains regulatory approval and clinical adoption, OrthoPreserve will seek to establish new reimbursement codes from payers to facilitate broader access and drive revenue growth. By demonstrating cost-effectiveness and improved patient outcomes, the company aims to position its implant as a value-based solution in the healthcare system, appealing to integrated health systems. Additionally, OrthoPreserve may explore revenue-sharing models with physician groups and partnerships with specialized care centers to increase adoption. Over time, geographic expansion and new indications for use, such as primary treatment for irreparable meniscus injuries, will open larger market opportunities. Post-market revenue could also include value-added services, such as surgeon training and surgical instrumentation packages. Together, these strategies will establish sustainable revenue streams while capturing a growing share of the orthopedic market.
OrthoPreserve is currently raising a $2M seed round in the form of a convertible note, and asking for direct investment or connections to other investors in the space. These funds will be used to complete the next stage of development needed to start clinical trials. This includes a GLP animal study, GMP manufacturing refinement and validation, completing FDA-required biocompatibility evaluations, and verifying long term (5 year) durability in dynamic fatigue testing. Funding will also be used to file additional IP for new design improvements, manufacturing methods, and implantation methods. The remainder of the funding will allow for building the team with full-time technicians, consultants, and fractional executives.
During initial development of the implant at Georgia Tech, significant bench-top mechanical testing showed that over 15 mechanical properties of the implant matched or exceeded those for the natural meniscus, demonstrating the implant's durability and functional performance. This work provided a final implant design, and the technology IP was licensed to OrthoPreserve in 2021 to continue development. Using an NIH SBIR grant, OrthoPreserve was able to complete a pilot animal study in sheep to demonstrate initial safety and efficacy, develop a minimally invasive (arthroscopic) surgical implantation technique in cadavers, and complete fatigue testing that showed the implant continues to restore normal joint mechanics after years of use. The OrthoPreserve team met with the FDA in 2024 to refine their regulatory strategy, and have already planned the next phase of development required to reach clinical trials in humans. This next phase will include an additional longer term animal study, manufacturing refinement and validations, and a few more FDA-recommended benchtop tests. Once this phase is complete, OrthoPreserve will have all the data required to obtain an Investigational Device Exemption (IDE) from the FDA to begin clinical trials. OrthoPreserve's meniscus implant was granted FDA's Breakthrough Device Designation in December 2024, which is intended to help patients have more timely access to designated medical devices by expediting their development, assessment, and review.
We were awarded an NIH SBIR Phase I grant for $305,000 in 2023, and have raised $100,000 from individual angel investors so far in our current Seed round.
