Moximed

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Overview

Moximed is a medical technology company based in Fremont, California, founded to develop innovative solutions for knee osteoarthritis (OA). Since its inception in 2008, Moximed has focused on pioneering joint unloading implants. The company's flagship product, the MISHA Knee System, is the world's first implantable shock absorber designed for the knee. Over its operational years, Moximed has successfully raised significant funding, including a notable $91 million Series D financing in 2024, to propel its commercialization efforts.

Recent Developments

  • October 2024: Moximed completed a $91 million Series D financing round to accelerate the commercialization of the MISHA Knee System. This round was led by Elevage Medical Technologies and included participation from new and existing investors. The funds will support expanding patient and surgeon access to their breakthrough technology.
  • August 2024: The company appointed Christopher Gleason as CEO, succeeding Anton Clifford. Michael Mydra joined as Senior Vice President for Reimbursement and Market Access, aimed at expanding access to the MISHA Knee System.
  • April 2023: The FDA granted marketing authorization for the MISHA Knee System. This implantable shock absorber showed superiority over the high tibial osteotomy in clinical trials, offering a pioneering non-replacement solution for patients with medial knee OA.
  • September 2023: Moximed began treating commercial patients in the U.S. with the MISHA Knee System post-FDA approval, marking a significant milestone in its healthcare delivery model.
  • May 2023: Peer-reviewed publications corroborated the benefit of the MISHA Knee System in reducing arthroplasty risk in high-risk patients, further validating its therapeutic potential.
  • January 2024: Moximed welcomed Dave Amerson to its Board, aiming to leverage his expertise in commercializing medical devices.

Company Information

AttributeInformation
Founding Date2008
HeadquartersFremont, California, USA
FoundersAnton Clifford
RevenueNot publicly disclosed
Key InvestorsNew Enterprise Associates, Gilde Healthcare, Vertex Ventures HC, Advent Life Sciences
IndustryMedical Devices
Number of Employees50-200 (estimate based on similar company scope)

Early History

Moximed was founded in 2008 by Anton Clifford with a vision to change the landscape of osteoarthritis treatment. Initially, the company developed the KineSpring System, which aimed to serve as a joint unloading solution, limiting the need for full joint replacement. The product received CE mark approval in Europe but was phased out in favor of a more advanced solution, the MISHA Knee System. The focus shifted to developing this new system, leveraging its benefits of reducing joint load without significantly altering knee anatomy. Early clinical trials in the U.S. laid the foundation for gaining regulatory milestones such as FDA approval.

Company Profile and Achievements

Moximed's business model revolves around providing advanced technological solutions to manage knee osteoarthritis. Its primary innovation, the MISHA Knee System, integrates a shock absorber mechanism capable of alleviating knee pain by reducing load burden on the joint. Key achievements include:

  • Clinical Validation: Moximed's MISHA System has shown superiority in clinical trials over traditional surgical methods, such as the high tibial osteotomy.
  • Regulatory Success: The company received FDA marketing authorization in April 2023, marking a crucial regulatory milestone.
  • Funding and Growth: Having raised significant capital, including a $40 million Series C and a subsequent $91 million Series D in 2024, Moximed strategically expanded their developmental and commercial capabilities.
  • Market Introduction: In 2023, Moximed successfully introduced the MISHA Knee System to commercial markets within the United States, post its FDA approval, with positive reception among patients and surgeons.

Current Operations and Market Position

Currently, Moximed operates with a strong focus on the further commercial rollout of the MISHA Knee System in the U.S. and Europe. Their operations are primarily centered around manufacturing, marketing, and providing educational programs to orthopedic surgeons. The MISHA system stands as a unique alternative to traditional knee surgeries, allowing patients to retain more of their natural joint structure for extended periods. Moximed is poised at the forefront of non-replacement knee solutions, and its strong investor support underscores its strategic market positioning.

Moximed FDA Approval

Moximed received FDA marketing authorization for its MISHA Knee System in April 2023. The FDA approval underscored a robust clinical trial record of safety and efficacy, as reported in pivotal studies. The unique implantable design provides an alternative for patients who are not candidates for knee replacement due to age or medical conditions.

Moximed MISHA

The MISHA Knee System is Moximed's flagship product, marketed as the first of its kind implantable shock absorber for knee osteoarthritis. This device is designed to reduce symptomatic joint load in patients, enabling delayed total knee replacement for many who are not suitable for surgery. The system serves as a first-line implant in managing early to moderate osteoarthritis in active individuals.

Conclusion

Moximed has significantly positioned itself in the orthopedic space, specifically targeting knee osteoarthritis with its innovative MISHA Knee System. With FDA backing and continued financial and strategic investment, the company stands at the cusp of substantial market penetration. Looking ahead, Moximed is well-equipped to meet growing demand for surgical alternatives, providing new hope to patients globally who seek to extend their active lifestyles without immediate joint replacement.

References

  1. MedCity News Coverage
  2. MassDevice News
  3. Gilde Healthcare Report
  4. Moximed Official Page
  5. FDA Approval Documentation