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Medical Devices

Aurora Spine Receives IRB Approval: To Commence Registration for Multicenter Study of its SiLO™ Device for SI Joint Pain

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Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced that it has received Institutional Review Board (IRB) approval for its new multicenter study of its SiLOTM SI Fusion System, which is intended for use on patients who require sacroiliac joint fusion surgery.

The system implants a bone allograft into the SI joint to stabilize and fuse the joint.

The IRB is an FDA-registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The SiLO registry will be conducted at up to 11 investigative sites in the United States and is anticipated that data from up to 60 subjects will be entered into the registry.

Trent Northcutt, Aurora Spine President, CEO and co-founder stated, “In the past few months, Aurora has been conducting advanced training sessions and cadaver labs that introduced leading neurosurgical, orthopedic, and pain management physicians to the SiLOTM SI Fusion System. With many procedures already completed, the SiLO system has been safe and effective in an outpatient setting. The IRB approval allows Aurora to launch a multicenter, prospective clinical study to investigate the efficacy of the SiLO device managing low back pain and improving quality of life in patients suffering from SI Joint pain.”

“This registry aims to provide interventional pain physicians in the United States with clinical data that supports the safety and effectiveness of the SiLO sacroiliac fixation technique. I am excited to be part of the study and to train others so that we can continue to advance therapies that relieve pain and restore function,” said Jack Diep, M.D., a Pain Medicine Specialist in Lake Havasu City, AZ. Dr. Diep has adopted this therapy with his patients as a minimally invasive alternative approach. Dr. Diep stated, “The launch of this registry will give the ability to produce published clinical outcomes utilizing a minimally invasive option to treat sacroiliac pathology.”

“SiLO carries features within the implant design and instrumentation that leads to a congruent fit of the graft within the sacroiliac joint allowing proven biomechanical stability with a single graft approach to posterior fixation,” said Steven Falowski, M.D., Director of Functional Neurosurgery at Argires-Marotti Neurosurgical Associates of Lancaster, PA . “The IRB approval to start the registry will now allow Aurora to obtain real world clinical evidence in its patients to demonstrate the efficacy and utility of this truly minimally invasive approach.”

“SiLO is an efficient posterior approach procedure which results in quicker post-op recovery times and better patient outcomes,” said Dr. Michael Stoffman, a Neurosurgeon at University at Buffalo Neurosurgery. “The SiLO study is an important milestone for the physician community as we are committed to helping patients experiencing chronic SI Joint pain by advancing the benefits of the SiLO procedure through vigorous clinical research.”

“The SiLO Registry will provide valuable clinical data regarding the safety and effectiveness of the SiLO system and its minimally invasive approach,” said Anish S. Patel, MD, MBA, managing partner at National Spine & Pain Centers. “The IRB approval for Aurora Spine’s study is a key step in gathering clinical evidence of the benefits of the SiLO system and its treatment of sacroiliac pain and better patient outcomes.”

The primary outcomes for this analysis will be change in patients’ self-reported pain, quality of life, and disability over time. Pain, quality of life, and disability will be assessed using the Visual Analog Scale in both the numerical and facial scales, the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), and the Oswestry Disability Index (ODI).

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Source: https://infomeddnews.com/aurora-spine-irb-approval/

Medical Devices

Brain Scientific Enters into Merger Agreement with Piezo Motion Closing Contemplates Minimum $5 Million Capital Investment For Combined Company

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NEW YORK, June 16, 2021 (GLOBE NEWSWIRE) — via InvestorWire – Brain Scientific Inc. (OTCQB: BRSF), a neurology-focused medical device and software company, announces today that it has entered into a definitive merger agreement to acquire Piezo Motion Corp., a leading innovator of high-precision piezoelectric motion technology.

The merger, upon its closing, is expected to expand the overall market reach of both companies and ability to deliver innovative technologies to high growth markets. Both companies bring a team of scientists, engineers, and executives experienced in developing and selling disruptive technologies. They combine elements of physical and social sciences with machine learning and understanding to address commercial demands in the market.

The combined company upon closing is expected to have a suite of stand-alone products that are able to work together in a cycle of data gathering, intelligent predictions, and precise actions. Brain Scientific’s neurology products are being designed to create massive amounts of data which, in turn, can be analyzed by artificial intelligence (“AI”) programs to aid doctors and researchers to recommend correct precision treatments. In the future, these are expected to be driven by Piezo Motion’s technology. 

Piezo Motion offers a suite of precision motion solutions that allow original equipment manufacturers (“OEM”) manufacturers to develop energy efficient precision products. These solutions have applications in advancing wearable drug delivery, surgical robotics, and other industrial precision applications in high growth markets such as autonomous vehicles and aerospace. 

“We are excited for the future that the merger with Piezo Motion is expected to bring. Together, we plan to achieve rapid expansion while delivering and developing the new generation of MedTech solutions for the brain diagnostics market, including innovative products for long-term monitoring and brain e-tattoo. This combination offers a significant opportunity to be part of a company well positioned for growth. We look forward to uniting with Piezo Motion in what we expect will be an exciting new chapter ahead.” – Dr. Baruch Goldstein, Founder of Brain Scientific.

“Brain Scientific and Piezo Motion come together with breakthrough proprietary technologies addressing fast-growing multi-billion-dollar markets in medical technology, pharmaceutical research, industrial automation, biotechnology and more.” –  Hassan Kotob, CEO of Piezo Motion.

The transaction is subject to customary closing conditions, including approval by the respective shareholders of both companies, as well as the successful consummation of a minimum $5 million capital raise. The transaction is expected to close in July 2021, subject to the closing conditions. At closing, Brain Scientific will acquire 100% of Piezo Motion’s outstanding shares and, accordingly, all of its assets and liabilities, and in return Piezo Motion’s shareholders will receive such number of shares of Brain Scientific’s common stock as would equal 100% of its issued and outstanding shares immediately prior to closing on an fully-diluted, as converted basis.

As part of the merger, Boris Goldstein and Nickolay Kukekov, directors of Brain Scientific, are expected to remain on the Board, with three new appointees from Piezo Motion. Hassan Kotob, currently CEO of Piezo Motion, will assume the role of Chairman and CEO of the combined company. The combined company will initially have offices in New York, Silicon Valley, Florida, and Europe.

About Brain Scientific
Brain Scientific is a commercial-stage healthcare company with two FDA-cleared products, providing next-gen solutions to the neurology market. The Company’s smart diagnostic devices and sensors simplify administration, shorten scan time and cut costs, allowing clinicians to make rapid decisions remotely and bridge the widening gap in access to neurological care. To learn more about our corporate strategy, devices, or for investor relations, please visit: www.brainscientific.com.

About Piezo Motion
Piezo Motion is a leader in piezo motor technology with a multi-million dollar investment in research and development of affordable piezoelectric motors to meet, and exceed, the needs of today’s global markets. The company is committed to the development of innovative piezoelectric polymer actuators and electrode components that enhance their functionality in a multitude of applications. It works with startups, OEMs, research institutions, and industrial companies from around the world empowering the visionaries behind their products. Visit piezomotion.com for more information.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of EEG products and services and piezo motor technology, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance, (iv) the successful closing of the transactions contemplated by the merger agreement with Piezo Motion and (v) the assumptions underlying or relating to any statement described in points (i), (ii), (iii) or (iv) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain additional financing, the significant length of time and resources associated with the development of products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, volatility in the price of the Company’s raw materials, failure to satisfy the closing conditions to the merger with Piezo Motion, and the failure to implement the Company’s business plans or strategies, including as a result of the closing of the merger with Piezo Motion. Some of these and other factors are identified and described in more detail in the Company’s filings with the SEC. The Company does not undertake to update these forward-looking statements.

Corporate Communications:
InvestorBrandNetwork (IBN)
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
Editor@InvestorBrandNetwork.com

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Source: https://www.biospace.com/article/releases/brain-scientific-enters-into-merger-agreement-with-piezo-motion-closing-contemplates-minimum-5-million-capital-investment-for-combined-company/?s=93

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Medical Devices

Relievant Medsystems Announces Publication of New INTRACEPT Trial Data Showing Sustained Relief from Chronic Low Back Pain 12 Months Post-Procedure

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MINNEAPOLIS, June 16, 2021 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced 12-month results from a Level 1, prospective, randomized, multi-center trial that demonstrated the effectiveness and superiority of the Intracept® Procedure for vertebrogenic CLBP compared to standard care treatments.

The INTRACEPT study randomized 140 patients across 20 sites and enrollment was stopped early due to statistical superiority at the pre-specified interim analysis; primary results were published in 2019, showing a significant difference between the Intracept arm and the standard care arm for the primary endpoint and all secondary endpoints at three months post-procedure.

The newly published data report outcomes for the full randomized trial cohort, including six-month between arm comparisons, 12-month treatment arm results, and six-month outcomes post-procedure for patients in the prior standard care arm that elected to crossover and receive BVN ablation upon the trial enrollment being stopped.

The published results demonstrate a 24.5 difference between arms in reduction in mean ODI, with BVN ablation arm (26.1 points, p<0.001) versus standard care arm (1.6 points, p<0.001) at six months post-procedure, validating superiority of the Intracept Procedure compared to standard care.

These outcomes continued through 12 months, with statistically significant and clinically meaningful reductions in mean ODI (25.7 points, p<0.001) and mean VAS (3.8 cm, p<0.001) from baseline through 12 months in the Intracept treatment arm.

Additionally, crossover patients who were re-baselined prior to receiving the Intracept procedure reported nearly identical outcomes, with reductions in mean ODI (25.9 points, p<0.001) and mean VAS (3.8 cm, p<0.001) compared to baseline at six months post-procedure.

Other key results from the study include:

  • 64% of patients in the Intracept treatment arm reported ≥50% reduction in pain, while 30% reported they had complete pain resolution at 12 months; similar reductions in pain were reported in crossover patients at six months post-procedure.
  • 92% of patients in the Intracept treatment arm who had epidural steroid injections prior to treatment did not have any injections in the 12 months after treatment. Crossover patients reported a 100% reduction in injections six months post-procedure.
  • 74% of patients in the Intracept treatment arm reported improvement of their condition, with 75% indicating treatment success at 12 months. Former standard care patients who crossed over to BVN ablation reported similar satisfaction at six months post-procedure (78% improvement, 72% success).
  • There were no serious device or procedure-related adverse events.

“Publication of the full INTRACEPT randomized trial results is an important step in proving the clinical effectiveness of BVN ablation and further validating its role in the CLBP care pathway,” said Matthew Smuck, MD, Physical Medicine & Rehabilitation, Stanford University. “Patients in the BVN ablation treatment arm demonstrated clinically and statistically significant improvements vs. those in the standard care arm, with benefits in pain and function lasting 12-months after treatment. Additionally, standard care arm patients who chose to receive BVN ablation reported results consistent with the treatment arm patients at three and six months – demonstrating reproducibility of treatment outcomes.”

“The positive outcomes from the full cohort of the INTRACEPT randomized trial add to the significant portfolio of long-term evidence post-BVN ablation, with patients in the BVN ablation arm showing consistent outcomes with prior long-term studies,” said Tyler Binney, President & CEO, Relievant Medsystems. “Following the publication of positive 5-year data from the SMART trial, these results further demonstrate that outcomes post-Intracept procedure are long-lasting, reproducible, and superior to standard care – with the potential to positively improve the lives of the millions of patients suffering from chronic vertebrogenic low back pain.”

The 12-month publication is currently available in Regional Anesthesia and Pain Medicine via open access and can be found at the following link: 
https://rapm.bmj.com/content/early/2021/05/23/rapm-2020-102259

Relievant will host a webinar on Wednesday, June 30 at 7 p.m. CDT to review the outcomes of the study. Register at: www.relievant.com/intracept12

The Intracept procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain in the United States.

About Relievant Medsystems
Relievant Medsystems is a privately held medical device company that is transforming the treatment of Chronic Low Back Pain (CLBP) with the Intracept® Procedure – a novel, clinically proven and commercially available treatment designed to improve the quality of life for the millions of patients suffering from CLBP from degenerative disc disease with Modic changes, a biomarker indicating that their pain is vertebrogenic in origin. Learn more at www.relievant.com.

Contact
Chris Geyen
Relievant Medsystems
(650) 368-1000
investors@relievant.com

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Source: https://www.biospace.com/article/releases/relievant-medsystems-announces-publication-of-new-intracept-trial-data-showing-sustained-relief-from-chronic-low-back-pain-12-months-post-procedure/?s=93

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Medical Devices

JMI Equity invests more than $120M in startup to help medical device companies navigate regulatory hurdles

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Software-focused growth investment firm JMI Equity invested more than $120 million in a startup building quality management software for medical device companies

Indianapolis-based Greenlight Guru said it has seen increased interest in the last year as regulatory changes, the shift to remote work and a strained supply chain kept many medical device companies on their toes.

The startup confirmed the fundraise, which was first reported by the Wall Street Journal. It plans to use the additional cash to add new capabilities to its platform and expand its customer base.

“We listened to the needs of the medical device industry and chose JMI Equity as a strategic partner because they are experts at achieving growth by putting the customer first,” CEO David DeRam said in a news release. “We’ve been extremely deliberate when taking on investment because we wanted to ensure we found the right partner for us and our customers. This partnership will allow us to accelerate the value we provide to our customers as we remain committed to helping medical device companies get their life-changing products to patients and achieve our mission of improving the quality of life.”

The startup brings many paper-based processes into software, helping medical device companies prepare regulatory submissions, and with design control and risk management.

For example, it uses machine learning to identify documents that might be affected by a proposed change order, making it easier to understand the potential downstream effects.

Greenlight Guru said it currently has more than 500 medical device customers. Some of them include Centese, a startup making an FDA-cleared device for post-operative surgical drainage, and Sandstone Diagnostics, a startup making a point-of-care testing device, according to its website.

Other startups are also working on different aspects of the medical device development process. For example, BrightInsight, which raised more than $100 million earlier this year, is working to make it easier for startups to develop health apps by helping them meet security and privacy requirements.

Photo credit: ra2studio, Getty Images

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Source: https://medcitynews.com/2021/06/jmi-equity-invests-more-than-120m-in-startup-to-help-medical-device-companies-navigate-regulatory-hurdles/

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Medical Devices

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

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Hyperfine, Inc., creators of the world’s first portable magnetic resonance imaging device, has named Scott Huennekens Executive Chairman of the Board.

Mr. Huennekens is a successful CEO, Chairman, board member, and entrepreneur, having been involved in more than 20 medtech startup, growth, and public companies with market valuations totaling over $20 billion and benefitting over 20 million patients with the therapies and diagnostics they deliver. As Executive Chairman, he will partner with recently announced President and CEO Dave Scott to build Hyperfine into a leading ecosystem in the brain and beyond. This will begin with the continuation of the rapidly expanding commercialization of the world’s first compact portable MRI system (FDA cleared in August 2020) and preparing Hyperfine for future growth and readiness for a public market offering. His prior company and board experience includes recent IPOs at Actus Medical and Envista, Verb Surgical/Google, Volcano, NuVasive, ViewRay, EndoChoice, Digirad and Edwards Lifesciences.

“As Hyperfine enters its next phase of expanding commercialization and business vision, Scott brings a valuable new perspective to the board given his successful experiences in launching and building new product categories, expanding clinical applications and digitizing product platforms. These experiences will accelerate our trajectory,” commented company founder Dr. Jonathan Rothberg, who will continue to serve on Hyperfine’s board. “His business track record speaks for itself, and his clear dedication to improving healthcare for patients with digital platforms that include image diagnosis and guidance, interventional therapies, robotics and AI perfectly aligns with our mission.”

Dave Scott, President and CEO of Hyperfine, who previously worked with Mr. Huennekens at Verb Surgical/Google added, “Scott has made a broad impact across the healthcare industry and is a practiced and experienced executive chairman. His experience leading healthcare organizations and ability to successfully navigate evolving digital, commercial, clinical and regulatory changes over time will provide me and the board with valuable perspective and insights—we are glad to have him join us to help guide Hyperfine to expand the clinical applications and utility of portable MR imaging.”

“I am thrilled to join the board of directors at Hyperfine to help advance its first of a kind, game-changing portable MRI. I have been deeply motivated and inspired by the company’s mission,” stated Scott Huennekens. “I look forward to working alongside my fellow board members and company management to advance this truly innovative technology, and I am extremely proud to support the Hyperfine team as they redefine the use of MRI in the brain to begin with, expand the clinical applications to many other use cases, as well as extend the utility and access of MRI around the world.”

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

Until its acquisition in 2019 by Johnson & Johnson, he served as President and CEO of Verb Surgical, a joint venture between Google and Johnson & Johnson, to build a next-generation digital surgery platform that included robotics, advanced visualization, therapeutic instruments, connectivity, and AI. Mr. Huennekens also led Volcano Corp., a leader in minimally-invasive therapy guidance in interventional cardiology, from startup to its IPO in 2006 and subsequent acquisition by Philips in 2015. Volcano grew its open precision guided therapy platform to more than 8,000 installs in cath labs around the world. Before this, he served as President and CEO at Digirad Corp., a diagnostic imaging solutions provider that went public in 2004. Digirad introduced the world’s first portable solid state gamma for nuclear cardiology imaging.

Ernst & Young recognized Mr. Huennekens as Entrepreneur of the Year. Goldman Sachs recognized him multiple times as one of the 100 Most Intriguing Entrepreneurs at its annual Builders & Innovators conference. He graduated Magna Cum Laude with a Bachelor of Science in Business Administration from the University of Southern California and earned his Master of Business Administration from Harvard Business School.

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Source: https://infomeddnews.com/hyperfine-adds-scott-huennekens-executive-chairman/

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