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Francis Medical Announces Positive Data from VAPOR 1 IDE Study for Water Vapor Ablation of Prostate Cancer

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MINNEAPOLIS, June 8, 2021 /PRNewswire/ — Francis Medical, Inc., a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, today announced positive results from the company’s VAPOR 1 clinical study evaluating the safety and efficacy of the company’s minimally invasive water vapor ablation therapy for treating prostate cancer.

VAPOR 1 is a prospective, multicenter, single-arm study that treated 15 patients with intermediate- risk, localized prostate cancer at four U.S. clinical sites. The data is from the six-month primary endpoint, including safety and efficacy outcomes, and VAPOR 1 study patients will continue to be followed to one year. Study participants had unilateral cancer (one side of the prostate), with a treatment intent of ablating only the impacted side (hemi ablation). The VAPOR 1 six-month data reported no serious adverse events, no device-related adverse events, and no unanticipated adverse device effects. Additionally, the effectiveness results support findings that demonstrate water vapor technology can reach and treat all prostate regions (apex, mid, base, anterior, and posterior) and eradicate intermediate risk, Grade Group 2 (GG2, Gleason Score 3+4), prostate cancer. In 87% of patients, six-month biopsy results indicate no ≥ GG 2 (clinically significant) disease on the treated side. In three patients, results on the treated side showed a single positive biopsy core with ≤ 5% involvement (low volume) of GG1 (Gleason Score 3+3) disease.

The safety profile reflects low levels of adverse events for the patient population treated, with no patients reporting urinary incontinence requiring pad usage and one (6.7%) patient reporting moderate erectile dysfunction (with medication indicated). These promising results support the intent of this therapy to manage clinically significant disease while decreasing morbidities associated with currently used prostate cancer treatments. Francis Medical will use the safety and efficacy data from the VAPOR 1 study to support a pivotal trial with its next-generation device and U.S. regulatory approval.

“I am excited to be participating in the VAPOR 1 trial,” said Dr. Christopher Warlick, head of the Department of Urology at the University of Minnesota and principal investigator in the VAPOR 1 study. “Currently, urologists commonly use water vapor to successfully treat benign prostatic hyperplasia (BPH). The VAPOR 1 results are very encouraging and suggest the viability of water vapor technology to treat prostate cancer as well. This approach has the potential to provide appropriate men a simple outpatient procedure to manage their prostate cancer with minimal risk of the debilitating side effects often seen with other therapies.”

As the second most common cancer in U.S. men, the American Cancer Society estimates one in nine American men will be diagnosed with prostate cancer during their lifetime. Prostate cancer is a serious disease for which current treatment options often cause complications such as urinary incontinence and erectile dysfunction. Francis Medical’s water vapor energy technology applies the thermal energy stored in a few drops of sterile water to deliver targeted treatments to the cancerous tissue in a simple transurethral procedure. The therapy is designed to ablate cancer cells while protecting surrounding structures, lessening the likelihood of life-altering side effects common with other prostate cancer treatments.

“We are thrilled with the results from VAPOR 1,” said Michael Kujak, Francis Medical president and chief executive officer. “We want to thank all of the VAPOR 1 investigators, their support staff and the patients suffering from prostate cancer who volunteered to participate for the extraordinary efforts required to execute this study through the worst of the COVID-19 pandemic. The excellent results of VAPOR 1 confirm our belief that this groundbreaking technology will ultimately become the first-line treatment of choice for men and their doctors.” 

“The VAPOR 1 results are the culmination of the hard work and shared vision of the entire Francis Medical team,” said Michael Hoey, Francis Medical founder and chief technology officer. “At Francis Medical, the patient is always first and foremost in our minds. Therefore, it is extremely gratifying to provide the patients in VAPOR 1 with not only an effective treatment for their cancer, but also one that produced minimal pain and side effects, allowing them to quickly return to their normal activities. We continue to work hard every day to realize our shared goal to bring this therapy to every man who can benefit from it.”

On the heels of these results, Francis Medical is currently in the process of raising Series B financing to fund their VAPOR 2 pivotal study.

About Francis Medical:
Francis Medical is committed to developing urological cancer treatments that are tough on cancer and gentle on patients, with a compassionate belief that minimally invasive therapies can effectively treat cancerous tissue. The company’s foundation is a tribute to and legacy of the inventor’s father, Francis Hoey, who endured prostate cancer treatments that had harsh implications on his everyday living before the disease took his life in 1991. Unfortunately, current prostate cancer treatments are not much different from what Francis Hoey encountered, with the typical side effects including urinary incontinence and erectile dysfunction. In contrast, water vapor technology applies the thermal energy stored in sterile water vapor to cancerous tissue via a simple transurethral procedure, potentially minimizing life-altering side effects. For more information on Francis Medical, visit www.francismedical.com or call (763) 951-0370.

Contact:  Michael Kujak, CEO
612-910-9790
Shelli Lissick, Bellmont Partners
651-276-6922

Cision View original content:http://www.prnewswire.com/news-releases/francis-medical-announces-positive-data-from-vapor-1-ide-study-for-water-vapor-ablation-of-prostate-cancer-301308037.html

SOURCE Francis Medical, Inc.

 

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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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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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MedX Announces Issuance of Shares as Compensation for Consulting Services

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MISSISSAUGA, Ontario–(BUSINESS WIRE)– MedX Health Corp. (“MedX” or the “Company”) (TSX-V:MDX) announces that, further to Acceptance from the TSX Venture Exchange, it has issued 360,000 common shares at a deemed issue price of $0.20 per share, representing a total consideration of $72,000, as compensation for consulting services rendered. The shares were issued pursuant to the prospectus exemption contained in NI 45-106 s. 2.24; subject to the criteria contained in NI 45-102 s. 2.6(3) being met, the shares are not subject to any restrictive hold period.

About MedX

MedX, headquartered in Mississauga, Ontario, is a leading medical device and software company focused on skin health with its SIAscopy® on DermSecure® telemedicine platform, utilizing its SIAscopy® technology. SIAscopy® is also imbedded in SIAMETRICS®, a well-regarded research system used to assess treatment effectiveness of a variety of skin conditions, including burns. The Company’s SIAscope® and other devices are manufactured in its ISO 13485 certified facility. The SIAscope® is a hand-held device that uses patented technology utilizing light and its remittance to view up to 2 mm beneath suspicious moles and lesions in a pain free, non-invasive manner, with the Company’s software then creating real-time images for physicians and dermatologists to evaluate all types of moles or lesions within seconds. These products are Health Canada, FDA, TGA and CE cleared for use in Canada, the US, Australia, New Zealand, the European Union, Turkey and Brazil. DermSecure® meets all privacy, security and relevant regulatory requirements in Canada, the US, Brazil, and the EU. MedX also designs, manufactures and distributes quality photobiomodulation therapeutic and dental lasers to provide drug-free and non-invasive treatment of tissue damage and pain. www.medxhealth.com

Forward-looking Statements

This press release does not constitute an offer of any securities for sale. This press release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. These forward-looking statements involve certain risks and uncertainties that could cause actual results to differ, including, without limitation, the company’s limited operating history and history of losses, the inability to successfully obtain further funding, the inability to raise capital on terms acceptable to the company, the inability to compete effectively in the marketplace, the inability to complete the proposed acquisition and such other risks that could cause the actual results to differ materially from those contained in the company’s projections or forward-looking statements. All forward looking statements in this press release are based on information available to the company as of the date hereof, and the company undertakes no obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this press release.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210615006218/en/

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Xlife Sciences AG: curasan AG and Xlife Sciences AG Cooperate in the Field of Regenerative Medicine

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ZUERICH, SWITZERLAND / ACCESSWIRE / June 16, 2021 / curasan AG, a leading global provider of biomaterials for bone and tissue regeneration in dental and orthopedic surgery, and Xlife Sciences AG have initiated a collaboration in the field of regenerative medicine. Under the agreement it is intended to develop, produce, certify and market new products with a focus on the musculoskeletal area and tissue regeneration.

The main emphasis of the collaboration lies on the biologization of bone substitute materials and the development of an innovative manufacturing process. In this context, on the one hand, bone replacement products are to be manufactured using 3D printing processes by a project company of Xlife Sciences AG. The first series of tests have already yielded promising results. On the other hand, carrier materials are to be optimized for improved biofunctionality with substances that promote bone growth. For this purpose, new types of modalities, so-called exosomes, are introduced into the bone substitute material. Exosomes are bioactive nanoparticles that are secreted by stem cells or obtained from human platelets; these contain, among other molecules, growth factors and microRNAs.

“The cooperation with Xlife Sciences AG and its project companies gives curasan access to the most modern manufacturing processes as well as promising new therapies in musculoskeletal regeneration. In particular, the use of exosomes in conjunction with the tried and tested curasan products has enormous potential in tissue regeneration, “says Dirk Dembski, CEO of curasan AG. The Exosome Market recorded sales of approximately $ 174.04M in 2020 and is expected to experience a CAGR (Average Annual Growth Rate) of 27.89% over the forecast period (2021-2026) *

*Source: https://www.mordorintelligence.com/industry-reports/exosomes-market

About Xlife Sciences AG
Xlife Sciences AG is a Swiss company with focus on investing in promising technologies in the life science industry. Xlife Sciences AG is building the bridge from research and development to healthcare markets by supporting researchers and entrepreneurs in positioning, structuring, developing and implementing their concepts. Together with industrial partners or universities, Xlife Sciences AG leads projects through the proof-of-concept phase after an invention disclosure or start-up. Subsequently, the firm focuses on out-licensing or selling the company, often with a combination of a strategic partnership. Xlife Sciences AG offers its investors direct access to the further development of innovative and future-oriented technologies at a very early stage.

For more information, please visit: www.xlifesciences.ch

About curasan AG
curasan develops, produces and markets biomaterials and medical devices for bone and tissue regeneration.

As a global technology leader in the future-oriented growth market of regenerative medicine, our company is specialized in biomimetic bone grafting materials mimicking biological structures for the use in orthopedics, traumatology, spine surgery and dental implantology.

Further information: https://www.curasan.de/en/company/about-us/

For media inquiries:
Dennis Lennartz, Head Investor Relations, Xlife Sciences AG, Tel. +41 44 385 84 60, dennis.lennartz@xlifesciences.ch

Andrea Weidner, Corporate Communications, curasan AG, Tel. +49 6027 40 900 51, pr@curasan.com

For scientific inquiries:
Dr. Frank Plöger, Chief Scientific Officer, Xlife Sciences AG, Tel. +41 44 385 84 62, frank.ploeger@xlifesciences.ch

SOURCE: Xlife Sciences AG

View source version on accesswire.com:
https://www.accesswire.com/651921/Xlife-Sciences-AG-curasan-AG-and-Xlife-Sciences-AG-Cooperate-in-the-Field-of-Regenerative-Medicine

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