Syntellix obtains product approval for India

On October 07, 2021, Syntellix obtained the license to bring five different product families of its revolutionary bioabsorbable magnesium-based implants to market from India’s Central Drugs Standard Control Organisation (CDSCO) for the Indian market. With this approval, the company’s global market access and the number of potential patients treated with the company’s MAGNEZIX® implants have expanded by 1.38 billion, bringing the total number of people who can be treated with the company’s MAGNEZIX® implants to 3.8 billion. 

According to DelveInsight’s Orthopedic Digit Implants Market Analysis, India is expected to grow at the highest CAGR in the forecasted period as the healthcare spending is expected to increase by 2.5 times already until 2025. Indian private healthcare sector alone can treat up to ten times as many people as Germany in total.

According to analysts, this approval is expected based on the clinical safety and efficacy of the patent-protected MAGNEZIX® implants. The company has expanded its business by using the difficult period of the coronavirus crisis to shape up growth potential by more than doubling the number of accessible patients since the beginning of the pandemic through new approvals in various future markets.

Syntellix is preventing healthcare-associated infections (HAIs) with its unique MAGNEZIX® implants that received CE approval and product registration in more than 65 countries around the globe. Implant removal surgeries, including all corresponding risks to human health, such as anaesthesia risks, refracture risks, HAI risks and even COVID-19 exposure, become obsolete if surgeons use MAGNEZIX® implants.

Bausch + Lomb Announces Positive Outcomes for Premium LuxSmart™ Intraocular Lenses

On October 07, 2021, Bausch + Lomb, a global eye health business of Bausch Health Companies Inc., declared positive outcomes following the one-year real-world evaluation of its premium LuxSmart™ lens since its European launch in 2020.

LuxSmart™ is in practice by 200 surgeons across 18 countries, offering continuous vision from distance to intermediate. It is the hydrophobic lens, designed with Pure Refractive Optics (PRO) technology, suitable for use in patients with some co-morbidities. It could be used to achieve near vision through micromonovision.

According to DelveInsight’s, Intraocular Lens Market Analysis, the analyst estimates that Bausch + Lomb is a leading player present in the market, and these positive results will further boost the demand for its product. The physicians have confidence in prescribing the LuxSmart™ and are estimated to have treated around 5,000 cataract patients worldwide, including more than 4,000 across Europe. Around 1.8 billion people worldwide are estimated to be affected by presbyopia by 2050, including 280 million across Europe. 

Mr. Mayank Nanavaty, the ophthalmic consultant at Nuffield Health Brighton Hospital UK, explains: “My patients increasingly prioritize intermediate and distance vision because modern life now mostly takes place at arm’s length via laptops, iPads, and eBooks. So, when I was asked to trial LuxSmart™, I was most interested. The design fulfills all my major asks: It is non-diffractive, spherical aberration-based, hydrophobic and, as a bonus, it comes preloaded. I have used it in my cataract patients with excellent outcomes and patient feedback has been phenomenal. LuxSmart™ stands out from other lenses for its wider continuous range of high-quality distance and intermediate vision that can be achieved without glare and halos. I’ve also discovered that around 30% of my patients also gain near vision, allowing them to read small print without glasses.”

Movair Announces Commercial Launch of Luisa Life Supporting Ventilator with High-Flow Oxygen Therapy

On October 11, 2021, Movair, formerly known as International Biophysics Corporation, announced the US commercial launch of Luisa, an advanced ventilator intended for use in homes, institutions, hospitals, or portable applications for both invasive and non-invasive ventilation. Luisa can be used through the FDA’s Emergency Use Authorization in response to the increasing need for safe and effective ventilators. It is a portable and compact home ventilator now available in the US and one of the first with the added benefit of high-flow oxygen therapy.

Rami Arfoosh, MD, FCCP, Pulmonary and Critical Care Specialist and Associate Professor of Medicine at Medical College of Georgia, AU/UGA Medical Partnership, said, “Life supporting ventilation with high-flow therapy using the Luisa device proved to be a true asset during the most recent COVID-19 surge. It provided a new option to meet the high-flow needs of some patients in their home environment. Those patients would have otherwise continued to occupy hospital beds because of the lack of equipment that meets their needs at home. Luisa also provides the unique feature of switching back and forth between high-flow nasal cannula (HFNC) and non-invasive ventilator (NIV) with different modes by the push of a button.”

David Shockley, CEO of Movair, said, “Increased respiratory patient illness, COVID-19 and product recalls have created a critical need for ventilators in the United States. We’re addressing this demand with the launch of Luisa, a portable and compact home ventilator, designed and made in Germany, that also provides patients with high-flow oxygen therapy. At Movair, we’re committed to advancing life-empowering respiratory therapies that help patients breathe better and live better. The launch of Luisa underscores this commitment.”

According to DelveInsight’s analyst, this commercial launch during the ongoing pandemic, COVID-19, will help treat the patients suffering from chronic respiratory failure due to chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). It will boost the market demand once when approved by FDA and can become a market leader.

Cochlear announces FDA approval and FDA clearance of first-of-its-kind Remote Care capabilities for Nucleus and Baha Systems

On October 12, 2021, Cochlear Limited, the global leader in implantable hearing solutions, received US Food and Drug Administration (FDA) approval and clearance for its Cochlear™ Remote Assist solution in the Nucleus® and Baha® Systems. The company plans to commercialize these products in spring 2022.

Tony Manna, President, Cochlear Americas, said, “Through Cochlear’s Remote Check and Remote Assist, our innovative and secure Remote Care solutions further enhance clinical practice by bringing more options for monitoring patient performance and optimizing hearing outcomes remotely – ultimately providing care when and where it’s needed. Our Remote Care solutions have been carefully designed and tested to meet rigorous quality and security standards, giving our hearing implant recipients and their hearing care professionals the confidence to receive and deliver quality care outside of a medical office.”

According to DelveInsight’s Age-related Hearing Loss Market Analysis, the market is dominated by few players such as Advanced Bionics, Cochlear, MED-EL GmbH, Nurotron Biotechnology, Oticon Medical, among others. The approval of Cochlear™ Remote Assist solution in the Nucleus® and Baha® Systems and their commercial launch will help the company capture a significant market share during the forecasted period.

Laborie Medical Technologies Acquires Pelvalon

On October 13, 2021, Laborie Medical Technologies Corp., a specialist medical technology company, has acquired Pelvalon, Inc., a privately-held medical device company located in Redwood City, CA.

Pelvalon has developed an innovative product called the Eclipse™ System, a non-surgical, patient-controlled device for women suffering from fecal incontinence (FI), a pelvic floor disorder that affects one in ten women.

Michael Frazzette, President & CEO of Laborie, said, “Laborie’s mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. Our mission is well served by the addition of Eclipse™ to help patients who suffer from this difficult condition.”

Yuriy Prilutskiy, Head of Patricia Industries North America, a part of Investor AB, and owner of Laborie, said, “Patricia Industries is committed to supporting Laborie in its mission to provide patients and healthcare professionals with innovative and effective therapeutic and diagnostic technologies that preserve and restore human dignity. This acquisition further supports Laborie’s long-term growth, leverages Patricia Industries’ healthcare and life sciences expertise, and aligns with our organization’s purpose of creating value for people and society by building strong and sustainable businesses.” 

According to the analyst, this acquisition will strengthen Laborie Medical Technologies Corp.’s reach in North America and help in capturing the market share.

New Test Data Confirm Particle™ Bulb from Know Labs Successfully Inactivates SARS-CoV-2 Variants

On October 13, 2021, Know Labs, Inc., an emerging leader in non-invasive medical diagnostics, announced that new independent test data have confirmed the efficacy of a light bulb produced by its wholly-owned subsidiary Particle, Inc., in inactivating multiple variants of SARS-CoV-2. These test data are based on research performed by Texas Biomedical Research Institute (Texas Biomed).

Phil Bosua, Know Labs CEO and Particle bulb inventor, said, “Texas Biomed is a world-renowned research institute specializing in infectious diseases. Having Particle bulbs tested by its team is an important step to confirm the bulb’s efficacy. We’ve seen other variants become a growing concern. Particle has the potential to help the world address this pandemic as well as assist with the control of other pathogens and viruses. We are very proud of what the Particle team has accomplished.”

The company has also moved towards the final step before starting commercial production as it has received product and packaging samples from its contract manufacturer in Asia.