Synergy Disc Replacement Inc
Overview
Synergy Disc Replacement Inc, often known as Synergy Spine Solutions, is a medical device company specializing in cervical disc replacement solutions. It was founded in 2005 and is headquartered in Louisville, Colorado. Synergy is celebrated for its flagship product, the Synergy Disc, an advanced cervical disc replacement designed to restore both motion and alignment to the spine. The company has raised approximately $30 million in funding, with the Series A round being led by Amzak Health Investors LLC.
Recent Developments
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September 2024: Synergy recently completed the patient enrollment for its 2-Level IDE clinical trial designed to test the Synergy Disc's safety and effectiveness against traditional anterior cervical discectomy and fusion (ACDF) procedures. This trial involves 200 patients across 24 clinical sites in the U.S. (Orthospine News).
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July 2023: The company enrolled its first patient for the U.S. IDE 2-Level clinical trial. The trial evaluates the Synergy Disc's performance on patients with degenerative disc disease at two contiguous vertebral levels (Spinal Surgery News).
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June 2023: Synergy completed its 1-Level IDE trial enrollment, involving 175 participants. This milestone supports its strategy to achieve pre-market approval in the U.S. The trial assesses the device's safety and efficacy against ACDF in patients with symptomatic cervical degenerative disc disease (OrthoSpine News).
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February 2024: Synergy Spine Solutions announced a successful $30 million equity financing round. The funds are allocated for completing its clinical trials, pursuing FDA approval, and expanding commercialization efforts internationally (BizWest).
Company Information
| Attribute | Information |
|---|---|
| Founding Date | 2005 |
| Headquarters | Louisville, Colorado, USA |
| Founders | A group including medical professionals and engineers |
| Revenue | Not specified |
| Profits | Not specified |
| Key Investors | Amzak Health, Laurier Startup Fund, Aurum Holdings, Keiretsu Forum, NorthSpring Capital Partners |
| Industry | Medical Device Manufacturing |
| Number of Employees | Approximately 10 |
Early History
Founded in 2005, Synergy Disc Replacement Inc was established with the objective of developing innovative solutions for spinal surgeries. The company focused on creating a cervical disc that could both restore motion and alignment to the spine, addressing limitations seen in conventional spinal fusion surgeries. Over the years, Synergy strengthened its team with seasoned professionals from the medical device industry, bolstering its capabilities in spine technology development and commercialization efforts.
Company Profile and Achievements
Synergy Disc Replacement Inc focuses on cervical disc technology that integrates alignment restoration with motion preservation, showcased in its product, the Synergy Disc. Key achievements include:
- Market Entry: Gaining commercial availability status across multiple international regions, including Canada, Australia, Europe, and more.
- Innovation: The Synergy Disc is designed with a unique lordotic core to restore sagittal alignment, enhancing the physiologic range of motion (Synergy Spine Solutions).
- Clinical Trials: Successfully completing enrollment for two major IDE trials – the single-level and two-level – to build towards U.S. market entrance.
- Funding Milestones: Raising significant Series A funding that supports clinical and regulatory pathways (ODT Magazine).
Current Operations and Market Position
Currently, Synergy Spine Solutions is heavily involved in clinical trials to gain approval from the U.S. FDA. The company's trials and developments are strategically tailored to support its expansion into the U.S. market. The innovative nature of the Synergy Disc positions the company well within the competitive field of cervical disc replacement solutions, outperforming traditional methods by ensuring both motion preservation and alignment correction. Although a smaller player compared to giants in the industry, Synergy holds promise due to its cutting-edge technology and robust clinical validation processes.
Conclusion
Synergy Disc Replacement Inc is a rising entity in the field of spinal surgery solutions, driving innovation with its flagship Synergy Disc product. The firm's meticulous focus on coupling motion and alignment restoration addresses a critical gap in spinal care therapeutics, marking it as a potentially pivotal entity in the market. With current trials progressing successfully, its strategic pathway to obtain FDA approval could significantly bolster its market presence and influence the future of spine surgery. With continued investment and innovative technology, the company’s trajectory seems poised for substantial growth in the coming years.