Le Lézard
Classified in: Health
Subject: FDA

SpinTech Receives FDA 510(k) Clearance for STAGE Technology


HOLLAND, Mich., Aug. 9, 2021 /PRNewswire/ -- Genesis Innovation Group's cultivate(MD) Capital Fund II LP, a fund focused on investments into early-stage healthcare companies with innovative technologies, announced today that one of their portfolio companies, SpinTech, has received FDA 510(k) clearance for their STAGETM magnetic resonance imaging software. SpinTech is a privately-held medical device company at the frontier of brain imaging and MRI technology that has developed a comprehensive software platform for improving the diagnosis and treatment of a wide range of neurological conditions.

Radiologists face the challenge of accurately detecting the biomarkers critical for proper diagnosis and treatment of brain disorders in a meaningful timeframe and within clinical workflows. STAGE is a powerful, rapid, multi-contrast imaging method that allows scanning the entire brain in roughly five minutes, unlocking the full potential of MRI.  STAGE provides sixteen different types of image contrasts, six of which are the critically important quantitative data. Effective quantitative data helps improve diagnostic accuracy and will show changes in a patient's situation between an initial scan and subsequent examinations. 

STAGE also collects other conventional images, with enhanced contrast, automatically delivering clinical image data back into the radiologists' workstations.  On top of this data, SpinTech has developed a suite of automated diagnostic reports, which continues to grow as improved data and clinical research drive the discovery of new biomarkers, new diagnoses and better conclusions. A more conclusive diagnosis leads to more effective treatment for the patient.

Ward Detweiler, President and CEO of SpinTech said, "STAGE's novel acquisition technique and post-processing software, which grew from the world's top MRI research groups, is designed to enhance visualization of biomarkers that couldn't be seen in the brain before while improving throughput and accuracy, making it a significant advancement in imaging. The FDA Clearance allows us to utilize STAGE to help patients in real clinical environments."

Matt Ahearn, Managing Director, cultivate(MD) Capital Funds said, "FDA clearance of STAGE sets the foundation for SpinTech's initial commercialization and scale. STAGE software is an MRI operating system with specialized scanning sequences. STAGE normalizes data from all MRI manufacturers and Tesla levels and will provide neuroradiologist's an un-paralleled platform for diagnostics and reporting."

The company, which has decades of technical and thought leadership in the field of MRI and a global network of clinical partners, has also developed a suite of automated biomarker detection tools, including reports for Parkinson's Disease and cerebral microbleed detection and is exploring utilization of the technology in other parts of the anatomy.

Mr. Detweiler added, "Providing research support is in our DNA.  Now, looking at practical applications, we will show how to tap the full potential of this product to help radiologists unlock new information from the brain."

About cultivate(MD) Capital Funds

As a medical device venture capital fund, cultivate(MD) is dedicated to bringing emerging health care innovations to market, with a special focus on medical device and orthopedic technologies. cultivate(MD) is focused on investing in early stage healthcare companies with innovative technologies that have demonstrated evidence of effectiveness. 

This press release does not constitute an offer to sell or solicitation of an offer to buy any securities in any offering of securities.  There will not be any sale of any securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Forwarding-Looking Statements
Certain statements in this press release constitute forward-looking statements. When used in this press release, the words "will," "anticipate," and similar expressions or the negatives thereof are generally intended to identify forward-looking statements. Such forward-looking statements, including the intended actions and performance objectives of the fund, its general partner, cultivate(MD), or any cultivate(MD) portfolio company referenced herein, involve known and unknown risks, uncertainties, and other important factors that could cause the actual results, performance, or achievements of the general partner, or any cultivate(MD) fund or portfolio company to differ materially from any future results, performance, or achievements expressed or implied by such forward-looking statements. No representation or warranty is made as to future performance or such forward-looking statements. All forward-looking statements in this press release speak only as of the date hereof.  The fund, its general partner, and cultivate(MD) expressly disclaim any obligation or undertaking to disseminate any updates or revisions to any forward-looking statement contained herein to reflect any change in its expectation with regard thereto or any change in events, conditions, or circumstances on which any such statement is based. 

 

SOURCE Genesis Innovation Group


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News published on 9 august 2021 at 07:12 and distributed by: