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Elcam Medical Joins Serenno Medical as Strategic Investor and Manufacturer of its Automatic Monitoring of Kidney Function Device

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January 20, 2021

Serenno Medical, developer of medical devices for patient monitoring in a hospital setting, announced today that Elcam Medical, a leading producer of medical devices, has invested  $1.5 million in the Company and will also manufacture SentinelTM, Serenno’s urine output and intra-abdominal pressure digital monitoring device for the detection of acute kidney injury (AKI). Elcam Medical join existing investors Alon Medtech and serial medical device inventor, entrepreneur and investor, Dr. Shimon Eckhouse.

The partnership announced today combines Serenno’s unique solution with Elcam’s superior manufacturing experience to deliver high quality products at a competitive price, that will enable the use of Sentinel in a variety of hospital environments.

Continuous kidney function assessment allows the early detection of AKI, a common condition in hospitalized patients that significantly increases risk of mortality during and after hospitalization. Accurate measurement of urine output (UO) is clinically accepted as the best method for monitoring changes in kidney function. However, UO is currently monitored intermittently and manually by ICU staff, therefore acute changes in urine flow are difficult to detect. Thus, kidney injury is often detected relatively late, sometimes after it is impossible to prevent further progression.

Beyond the high death toll associated with kidney failure routinely in the ICU, the recent spread of COVID19 had greatly increased prevalence of, and death from AKI, while vastly increasing the demand and exposure risk on medical professionals and ICUs worldwide.

Sentinel offers a simple and cost-effective solution for the precise, continuous measurement of urine volume and flow rate in real time. The system promotes early detection of kidney injury, while there is still time to intervene and prevent further damage. It aims to automatically and accurately detect small changes in kidney function, allowing remote detection by the medical staff, thus reducing both patient and caregiver risk.

“The investment by Elcam Medical is a strong endorsement, and will allow us to swiftly move toward commercialization of our device,” said Tomer Lark, Serenno’s co-founder and CEO. “Elcam’s world class production capabilities and experience, will enable mass production and increased market access of Sentinel. Our plan is to begin deployment of the devices in several US hospitals towards the end of 2021, in the hope to eventually reduce kidney failure risk for every patient at ICUs.”

Dr. Shimon Eckhouse, Serenno’s Chairman, added, “We are pleased with Elcam’s investment, which marks the first commitment in Serenno’s larger planned current financial round. This partnership with Elcam is an excellent indication of the high degree of innovation and the significance of Serenno’s solution for the advancement of monitoring technologies. We are confident that Elcam’s leadership position in the global point-of-care market will play a critical role in bringing Serenno’s exciting technology to ICUs and patients around the world.”

“Our investment in Serenno and the establishment of a production line for its device is aligned with Elcam’s strategy to cooperate with promising Israeli startups to deliver products with added value for the patient,” said Igal Kohn, Elcam Medical’s CEO. “Elcam Medical has joined Serenno as a board member and we look forward to taking part in the Company’s continued successes.”

Source: https://infomeddnews.com/elcam-medical-joins-serenno-medical-as-strategic-investor/

Medical Devices

How Rani Therapeutics’ robotic pill could change subcutaneous injection treament

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A new auto-injecting pill might soon become a replacement for subcutaneous injection treatments.

The idea for this so-called robotic pill came out of a research project around eight years ago from InCube Labs—a life sciences lab operated by Rani Therapeutics Chairman and CEO Mir Imran, who has degrees in electrical and biomedical engineering from Rutgers University. A prominent figure in life sciences innovation, Imran has founded over 20 medical device companies and helped develop the world’s first implantable cardiac defibrillator.

In working on the technology behind San Jose-based Rani Therapeutics, Imran and his team wanted to find a way to relieve some of the painful side effects of subcutaneous (or under-the-skin) injections, while also improving the treatment’s efficacy. “The technology itself started with a very simple thesis,” said Imran in an interview. “We thought, why can’t we create a pill that contains a biologic drug that you swallow, and once it gets to the intestine, it transforms itself and delivers a pain-free injection?”

Rani Therapeutics’ approach is based on inherent properties of the gastrointestinal tract. An injecting mechanism in their pill is surrounded by a pH-sensitive coating that dissolves as the capsule moves from a patient’s stomach to the small intestine. This helps ensure that the pill starts injecting the medicine in the right place at the right time. Once there, the reactants mix and produce carbon dioxide, which in turn inflates a small balloon that helps create a pressure difference to help inject the drug-loaded needles into the intestinal wall. “So it’s a really well-timed cascade of events that results in the delivery of this needle,” said Imran.

Despite its somewhat mechanical procedure, the pill itself contains no metal or springs, reducing the chance of an inflammatory response in the body. The needles and other components are instead made of injectable-grade polymers, that Imran said has been used in other medical devices as well. Delivering the injections to the upper part of the small intestine also carries little risk of infection, as the prevalence of stomach acid and bile from the liver prevent bacteria from readily growing there.

One of Imran’s priorities for the pill was to eliminate the painful side effects of subcutaneous injections. “It wouldn’t make sense to replace them with another painful injection,” he said. “But biology was on our side, because your intestines don’t have the kind of pain sensors your skin does.” What’s more, administering the injection into the highly vascularized wall of the small intestine actually allows the treatment to work more efficiently than when applied through subcutaneous injection, which typically deposits the treatment into fatty tissue.

Imran and his team have plans to use the pill for a variety of indications, including the growth hormone disorder acromegaly, diabetes, and osteoporosis. In January 2020, their acromegaly treatment, Octreotide, demonstrated both safety and sustained bioavailability in primary clinical trials. They hope to pursue future clinical trials for other indications, but chose to prioritize acromegaly initially because of its well-established treatment drug but “very painful injection,” Imran said.

At the end of last year, Rani Therapeutics raised $69 million in new funding to help further develop and test their platform. “This will finance us for the next several years,” said Imran. “Our approach to the business is to make the technology very robust and manufacturable.”

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Source: https://techcrunch.com/2021/03/05/how-rani-therapeutics-robotic-pill-could-change-subcutaneous-injection-treament/

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Medical Devices

How Rani Therapeutics’ robotic pill could change subcutaneous injection treament

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Published

on

A new auto-injecting pill might soon become a replacement for subcutaneous injection treatments.

The idea for this so-called robotic pill came out of a research project around eight years ago from InCube Labs—a life sciences lab operated by Rani Therapeutics Chairman and CEO Mir Imran, who has degrees in electrical and biomedical engineering from Rutgers University. A prominent figure in life sciences innovation, Imran has founded over 20 medical device companies and helped develop the world’s first implantable cardiac defibrillator.

In working on the technology behind San Jose-based Rani Therapeutics, Imran and his team wanted to find a way to relieve some of the painful side effects of subcutaneous (or under-the-skin) injections, while also improving the treatment’s efficacy. “The technology itself started with a very simple thesis,” said Imran in an interview. “We thought, why can’t we create a pill that contains a biologic drug that you swallow, and once it gets to the intestine, it transforms itself and delivers a pain-free injection?”

Rani Therapeutics’ approach is based on inherent properties of the gastrointestinal tract. An injecting mechanism in their pill is surrounded by a pH-sensitive coating that dissolves as the capsule moves from a patient’s stomach to the small intestine. This helps ensure that the pill starts injecting the medicine in the right place at the right time. Once there, the reactants mix and produce carbon dioxide, which in turn inflates a small balloon that helps create a pressure difference to help inject the drug-loaded needles into the intestinal wall. “So it’s a really well-timed cascade of events that results in the delivery of this needle,” said Imran.

Despite its somewhat mechanical procedure, the pill itself contains no metal or springs, reducing the chance of an inflammatory response in the body. The needles and other components are instead made of injectable-grade polymers, that Imran said has been used in other medical devices as well. Delivering the injections to the upper part of the small intestine also carries little risk of infection, as the prevalence of stomach acid and bile from the liver prevent bacteria from readily growing there.

One of Imran’s priorities for the pill was to eliminate the painful side effects of subcutaneous injections. “It wouldn’t make sense to replace them with another painful injection,” he said. “But biology was on our side, because your intestines don’t have the kind of pain sensors your skin does.” What’s more, administering the injection into the highly vascularized wall of the small intestine actually allows the treatment to work more efficiently than when applied through subcutaneous injection, which typically deposits the treatment into fatty tissue.

Imran and his team have plans to use the pill for a variety of indications, including the growth hormone disorder acromegaly, diabetes, and osteoporosis. In January 2020, their acromegaly treatment, Octreotide, demonstrated both safety and sustained bioavailability in primary clinical trials. They hope to pursue future clinical trials for other indications, but chose to prioritize acromegaly initially because of its well-established treatment drug but “very painful injection,” Imran said.

At the end of last year, Rani Therapeutics raised $69 million in new funding to help further develop and test their platform. “This will finance us for the next several years,” said Imran. “Our approach to the business is to make the technology very robust and manufacturable.”

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Source: https://techcrunch.com/2021/03/05/how-rani-therapeutics-robotic-pill-could-change-subcutaneous-injection-treament/

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Ecommerce

UAT Group Inc, Acquires 20% of Next Casting Technologies

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Tampa FL, March 4th,2021 – OTC PR WIRE – Umbra Applied Technologies Group, Inc (OTC Pink: UATG) announced today that it has purchased 20% of the Austin, Texas based medical company Next Casting Technologies. The global orthopedic casting, splinting, braces and support market was valued at US $4.6 billion in 2015 and is expected to reach US $7.9 billion by 2024, at a CAGR of 6.4%. Next Casting Technologies has projected its first-year revenues to be $16.1M once it launches with a five-year evaluation in excess of $80M. UAT Group will deliver the $5M purchase price amortized over the next 24 months.

Chief Executive Officer, Alex Umbra commented, “Next Cast represents the tip of the spear in casting technology. What they have created is impressive and singular in the market. We initially partnered with NextCast on producing one of the components in their next generation cast which utilizes our industry leading antimicrobial technology Hygieia. After 2 years of collaborating on this unique project, it seemed only natural to have Next Cast become part of our family in a more definitive way. This addition to our suite of companies supports our commitment to building value within our subsidiary and strategic network”.

Next Casting Technologies (NCT) founded in 2016, is a research and design-centric, biomedical technology company, with an expanding portfolio of intellectual property. The NCT team of experienced engineers, designers, certification experts and business professionals combine advanced design with paradigm shifting technology engineered to disrupt and transform the casting, bracing and splinting space.

The current SmartCast technology is ready for commercial production and introduction into the market, with advances in second generation models currently under development. The next generation SmartCast will feature an integrated microprocessor not just for simplifying and managing the cast curing time, but will also include the ability to detect swelling, and promote the fracture healing process with active bone growth stimulation. Their patent pending technology provides multiple pathways for product line expansion within the lucrative specialty casting and custom bracing markets.

The CEO and inventor of the NCT product line stated,” We are currently in the final stages of initial commercial production and building domestic sales.  As revenue increases, design and production work will continue to expand product offerings to include bracing, splinting and specialty casting, utilizing NCT’s unique technology.  Over the next 36 months, the NCT Board vision is to guide the company into an international brand. We are currently engaged with a national medical products and service provider to provide our product lines to their clients. I know I speak with everyone at Next Cast when I say we could not be more excited about our future with our new strategic partner UAT Group”.

For more information about Next Cast go here: https://www.nextorthocast.com/

About Umbra Applied Technologies Group, Inc.:

The firm is located in Tampa Florida and focuses on advanced technologies across many disciplines. UAT Group is a holding company with interests in both public and private companies during the early stages of development as well as growth stages of companies with a synergistic business model to UAT Group subsidiaries.

For more information visit www.uatgroup.com

Investor and Media Contact: UAT Group at info@uatgroup.com

NEITHER THE SECURITIES EXCHANGE COMMISION NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS NEWS RELEASE.

Forward-Looking Information

This news release may include “forward-looking statements” including forecasts, estimates, expectations, and objectives for future operations including but not limited to its ability to conclude a business combination with a third party, sale of assets, return of capital or initial public offering and a secondary listing on the OTC as a result of aforementioned and its ability to fund the exploration of its assets through the raising of equity or debt capital or through funding by a joint venture partner that are

subject to a number of assumptions, risks, and uncertainties, many of which are beyond the control of Umbra Applied Technologies Group including but not limited to capital markets and securities risks and continued development success on technology. There can be and are no actual or implied guarantees that any of the above activities will be completed or completed on terms acceptable to the Company and its shareholders or approved by any regulatory authority having jurisdiction. Such forward-looking information represents management’s best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Umbra Applied Technologies Group does not assume the obligation to update any forward-looking statement, except as required by applicable law.

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Source: https://otcprwire.com/uat-group-inc-acquires-20-of-next-casting-technologies/

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Medical Devices

BioIntelliSense Partners with Leukemia & Lymphoma Society to Incorporate the BioSticker™ Medical Device for Continuous Monitoring in Clinical Trials

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DENVER, March 4, 2021 /PRNewswire/ — BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, today announced the company has entered into a strategic partnership with  The Leukemia & Lymphoma Society (LLS) to incorporate use of the BioSticker™ medical wearable device and data services in clinical trials of hematological cancer patients.  

The BioSticker is the first FDA-cleared single-use medical device that enables 30 days of continuous vital signs monitoring. The BioIntelliSense medical grade Data-as-a-Service (DaaS) platform and FDA 510(k) Class II medical wearable device provides a new standard for Remote Patient Monitoring (RPM), by combining an effortless patient experience with medical grade clinical accuracy, for cost-effective virtual trials.

The LLS clinical trials will include use of the BioSticker medical device for the continuous collection of vital sign and physiological data which includes temperature, heart rate, respiratory rate at rest, activity level and body position. The BioSticker data services and advanced analytics will be used by LLS to correlate symptoms to treatment.

James Mault, MD, CEO of BioIntelliSense, commented, “Our medical grade devices and data services can have a profound impact on oncology care by unlocking unique and actionable clinical intelligence to guide treatment decisions. It is a major focus of our company and we are extremely proud to be partnering with The Leukemia & Lymphoma Society as a global leader in blood cancer research and support services.”

About BioIntelliSense

BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM). Its medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multi-parameter vital signs, physiological biometrics and symptomatic events through an effortless patient experience. The FDA-cleared BioSticker™ and BioButton™ devices make remote monitoring and early detection simple. Through the platform’s advanced analytics, clinicians will now have access to high-resolution patient trending and reporting to enable medical grade care at home.

For more information on how BioIntelliSense is redefining remote patient monitoring through medical-grade and cost-effective data services, please contact us at info@biointellisense.com or visit our website at BioIntelliSense.com.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against cancer. The LLS mission: cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949 and headquartered in Rye Brook, NY, LLS has regional offices throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the LLS Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m., ET.

Media Contact

BioIntelliSense, Inc.
Carolyn Walsh
Chief Commercial Officer
cwalsh@BioIntelliSense.com

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/biointellisense-partners-with-leukemia–lymphoma-society-to-incorporate-the-biosticker-medical-device-for-continuous-monitoring-in-clinical-trials-301240198.html

SOURCE BioIntelliSense, Inc.

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Source: https://www.biospace.com/article/releases/biointellisense-partners-with-leukemia-and-amp-lymphoma-society-to-incorporate-the-biosticker-medical-device-for-continuous-monitoring-in-clinical-trials/?s=93

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