RMR Ortho, LLC

 Company Name

Presentation Objectives
RMR Ortho, LLC is privately held orthopedic medical device company committed to serving surgeons and their patients by providing the most advanced and effective bone fixation solutions to improve clinical outcomes for lower extremity applications.

Currently, a clinical compromise exists requiring foot and ankle orthopedic surgeons performing procedures requiring continuous compression to sacrifice implant strength for anatomic fit and vice versa. To address this issue, RMR Ortho developed a new generation of Nitinol implants that achieve maximum stability with minimum profile and is preparing for a Q3 2023 510(k) submission to the FDA.  The founders have extensive experience with regulatory submissions, regulatory approval, and commercialization of this specific technology. There are already approved reimbursement codes for this technology. Our goal is to secure $1.5-2M in funding for post-submission activities related to commercialization in order to enter the $2.1B North America lower extremity osteosynthesis market, currently growing at 8.2% CAGR.

Company Background
RMR Ortho, LLC is an orthopedic medical device company committed to serving surgeons and their patients by providing the most advanced and effective bone fixation solutions to improve clinical outcomes for lower extremity applications.

RMR was founded by Joe Ritz and Eric Marcano.  Joe Ritz, MSE, MBA, has over 30 years of proven leadership and is a pioneer in the medical device industry.  Specifically, he spearheaded the most recent evolution in Nitinol orthopedic implant technology resulting in over a dozen FDA clearances of Nitinol medical devices.   His leadership skills and ability to manage ventures with limited resources have resulted in successful divestitures of multiple start-ups.

Eric Marcano has over thirty years of diverse experience in healthcare and medical devices. A USAF Veteran and former Olympic-level Certified Athletic Trainer, Eric has 17 years of Nitinol implant expertise, training & education, strategic marketing and is co-inventor of sterile-packed Nitinol bone implant kits. Combined, Joe and Eric have over 30 patents granted and/or pending in the field of the use of Nitinol in orthopedic applications.

Technology & Current Research
Nitinol is a metal alloy of nickel and titanium, where the two elements are present in roughly equal atomic percentages.  Nitinol is a well-established biocompatible material that has been widely used for various implant applications in orthopedics, vascular stents, orthodontics, and other medical devices.

Nitinol is well-suited for orthopedic implants used to repair bone fractures and for bone fusion applications. Where traditional forms of fixation may achieve compression at the time of application, when faced with natural bone healing processes, they are unable to self-adjust to maintain that compression long-term.  In contrast, Nitinol bone implants have shape memory and superelastic characteristics that allow them to change shape over time and squeeze bones together to maintain compression. This compression between two bone segments results in enhanced stability and reduced motion, key components that optimize the environment required for successful bone fusion. Over the last decade, these implants have matured in their design and performance, as well as simplicity of use  leading to clinical success and rapid adoption by surgeons in forefoot in midfoot applications. But there are limitations. The use of this exciting technology currently requires compromise between maximizing strength and minimizing profile. For example, to fit their anatomy, some patients may require smaller implants that are not strong enough for the intended use. Likewise, to handle high loads applications, some patients require stronger implants that, due to current manufacturing methods, are bulky. Due to this compromise, many surgeons are still hesitant to adopt this technology in high load applications. RMR Ortho is focused on optimizing the performance of this technology in forefoot and midfoot applications as well as expanding its use into hindfoot and ankle procedures, higher load applications.

Partnership Strategy
As a sub-segment of the osteosynthesis market, the Nitinol bone fixation market is approximately $125M and growing at 8.3% CAGR, even without significant use in the hindfoot and ankle. While mostly fueled by research and development conducted by start-ups, larger companies are investing significant resources to build their Nitinol portfolios. These include numerous recent acquisitions by Johnson & Johnson (BioMedical Enterprises and CrossRoads Extremity Systems), Enovis (MedShape Technologies), and Stryker (Wright Medical), among others, leaving few small innovators remaining to continue to advance the technology.

Other larger strategics in orthopedics are still in need of this technology to support their portfolios. With unparalleled expertise in this field and a new, cutting-edge implant system, RMR Ortho is poised to achieve great value and success by filling this need. Our goal is to partner with one of these entities through distribution or possible acquisition.

Recent Milestones
Since the formation of RMR Ortho, a solid business plan has been created, and Pre-Seed and Seed round funding has been raised (~$400K).  Strategic development and manufacturing agreements have been established and essential intellectual property for foot and ankle application has been licensed.  Design feasibility has been proven and functional implant and instrument prototypes have been developed.  Manufacturing plans are in place to ensure competitive cost of goods is possible and the production of clinical quality implants is underway. Testing of these first products is due to be completed in the coming weeks with documentation currently prepared to support FDA regulatory submission in August 2023 for the US market via the 510(k) process.

Anticipated Milestones
Upon receipt of Series A Round funding (~$2M), preparations for launch of the new Nitinol fixation system will proceed with inventory builds to be ordered and distribution agreements established.  Upon 510(k) regulatory clearance, the system will undergo a soft launch in the US market to obtain clinical data followed by a full launch approximately 6 to 9 months later. Development will also commence for new products in the R&D pipeline to further support commercial growth.

Expected launch of First Product