HR Pharmaceuticals, Inc. Received Exclusive Commercialization Rights to Poiesis Medical’s Dual Balloon Catheter Technology in North America

On December 28, 2023, HR Pharmaceuticals entered into a collaboration with Poiesis Medical LLC, to license Poiesis’s Dual Balloon Catheter (Duette™). According to the terms of the agreement, HR Pharmaceuticals will exercise exclusive commercialization rights in North America. The product broadens HR Pharmaceuticals expanding urological portfolio across the continuum of treatment. The DuetteTM has a unique design to manage adverse events associated with Foley Catheterization, which is particularly significant for certain patient populations.

On January 2, 2024, HR Pharmaceutical started processing orders for the Duette Dual Balloon Catheters in North America.

“The Dual Balloon Catheter has demonstrated significant benefits compared to traditional Foley catheters, leading to better patient outcomes. Specifically, we see a great opportunity for patients requiring indwelling catheterization greater than five days. This product will become an important part of our broader urology strategy over the next 12 months,” commented Colby Wiesman, President of HR Pharmaceuticals, Inc. 

“The Dual Balloon Catheter technology, a brainchild of my father, Dr. Bruce Wiita, a practicing urologist and decorated Vietnam veteran, was born out of a genuine desire to improve the quality of life for patients enduring prolonged catheterization and to alleviate the strains it places on the healthcare system,” said Gregory Wiita, CEO and Founder at Poiesis Medical LLC. Gregory added, “We are excited about this new chapter with HR Pharmaceuticals and the potential of the technology to make a meaningful impact in patient care.” 

As per DelveInsight’s “Balloon Catheters Market” report, the global balloon catheters market was valued at USD 4.60 billion in 2022, growing at a CAGR of 8.78% during the forecast period from 2023 to 2028 to reach USD 7.62 billion by 2028. Factors such as the rising prevalence of lifestyle disorders such as hypertension and obesity which present themselves as major risk factors for the development of cardiovascular diseases as well as brain aneurysms, increasing incidence of cancers in the pelvic region affecting the urinary system in varying capacities, growing geriatric population base where age itself plays a major role in disease etiology, and technical innovation in product development such as manufacture of drug-coated balloon catheters aimed at drug delivery at the site of action among other factors are expected to drive the balloon catheters market.

Enovis Completed the Acquisition of Lima Corporate 

On January 3, 2024, Enovis acquired the orthopedic company Lima Corporate. Lima Corporate is engaged in creating patient-specific hardware and digital innovations. The company also seeks to enhance joint replacement surgery patient outcomes and provide doctors with more authority. 

The acquisition included a sum of USD 740.6 million cash payment at closing. The leftover USD 105.8 million will be paid in the form of shares of Enovis common stock.

According to Enovis, adding Lima created a USD 1 billion reconstruction business and broadened its global reach in the international markets. The company also anticipated that with the addition of Lima, it would experience increased productivity due to the presence of state-of-the-art manufacturing facilities. 

“We are excited to welcome Lima’s talented team to Enovis,” said Matt Trerotola, Chair and CEO, of Enovis. Matt added, “The combination brings Enovis’ recon segment to $1 billion in revenues and creates a fast-growing innovator in the global orthopedic reconstruction market. This is another great example of how we use strategic acquisitions to accelerate our growth, add great technologies and talent to our company, and drive compounding value for our shareholders.”

According to DelveInsight’s “Orthopedic Implants Market” report, the global orthopedic implants market is estimated to grow at a CAGR of 5.46% during the forecast period from 2023 to 2028. The orthopedic implants market is slated to witness prosperity owing to factors such as the increasing prevalence of orthopedic diseases such as arthritis, osteoporosis, and others, a growing burden of the geriatric population, the rising number of road accidents associated and other injuries, and the growing focus on improving the safety, affordability, and usability of orthopedic implants for people are further expected to result in the appreciable revenue growth in the orthopedic implants market during the forecast period (2023-2028).

AnX Robotica Announced FDA Clearance for ProScan™: A Groundbreaking AI-Assisted Reading Tool for Small Bowel Video Capsule Endoscopy

On January 03, 2024, AnX Robotica announced that it had received approval from the US Food and Drug Administration (FDA) for its NaviCam ProScanTM. 

ProScan is the first AI-assisted reading tool created to support small bowel capsule endoscopy reviewers for adult patients whose capsule endoscopy images were taken for suspected small bowel bleeding. 

With the use of cutting-edge technology, ProScan software, an artificial intelligence (AI) assisted reading tool, is revolutionizing the field of gastroenterology. AnX Robotics ProScan is a major advancement in capsule endoscopy since it provides doctors with the newest technologies to treat patients effectively. Further, ProScan software is a useful tool that enhances physician knowledge. It is not intended to take the role of a doctor’s clinical judgment however, it functions as a support system, empowering medical practitioners to make efficient judgments quickly and effectively with the aid of AI-assisted readings.

“As a clinician deeply immersed in the field of gastroenterology, I am thrilled to witness the FDA clearance of ProScan. This groundbreaking AI-assisted reading Tool represents a pivotal advancement in small bowel capsule endoscopy, particularly for patients suspected of gastrointestinal bleeding”, stated Dr. Cristiano Spada, Professor of Gastroenterology and Director of Endoscopy and Digestive Surgery at Gemelli Hospital. Dr. Cristiano added, “This clearance marks a significant leap forward in our pursuit of elevating patient care standards and signifies a new era in gastroenterological diagnostics.”

“We are delighted to announce the FDA clearance of NaviCam ProScan, a transformative AI Assisted Reading Tool that addresses a critical need in the realm of small bowel capsule endoscopy,” said Stu Wildhorn, Vice President of Marketing and Product Management at AnX Robotica. Stu Wildhorn added, “ProScan’s clearance underscores its potential to significantly enhance diagnostic workflows, allowing clinicians to make more informed decisions on time.”

According to DelveInsight’s “Endoscopy Cameras Market” report, the global endoscopy cameras market is estimated to grow at a CAGR of 5.63% during the forecast period from 2023 to 2028. The increase in demand for endoscopy cameras is primarily attributed to the increasing prevalence of chronic diseases that require the use of endoscopy cameras for diagnosis and visualization of some disorders, such as some gastrointestinal diseases like irritable bowel syndrome (IBD), gastroesophageal reflux disease (GERD), peptic ulcer disease, and Crohn’s disease, increase in several geriatric populations who are more prone to chronic ailments, increasing awareness and demand of minimally invasive surgeries, and rise in technological advancements in endoscopy cameras like image magnification, high-definition optical systems and digital imaging are anticipated to bolster the market, thereby contributing to the growth of the endoscopy cameras market during the forecast period from 2023-2028.

CGBio’s ‘NOVOSIS PUTTY’ Received FDA ‘Breakthrough Device Designation,’ Accelerate Entry into the US Market 

On January 02, 2024, CGBio, a South Korea-based company specializing in bio-regenerative medicine, announced that its advanced bone substitute material, “NOVOSIS PUTTY”, received ‘Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA). 

CGBio’s NOVOSIS PUTTY becomes the first product for implantable devices in Korea to receive a breakthrough designation. The effectiveness and novel features of NOVOSIS PUTTY are acknowledged globally, despite being a high-risk permanent implant.  

NOVOSIS PUTTY is a second-generation product that combines innovative sustained-release formulation technology (SLORELTM) from NOVOSIS Ortho with a ceramic-based synthetic scaffold that has enhanced moldability and osteoconductive qualities. A key component in NOVOSIS PUTTY is rhBMP-2, this protein is essential for bone regeneration because it converts stem cells into bone cells when there is a bone deficiency. Nebotermin which is another name for rhBMP-2, has been globally recognized for its positive effects on health.

Hyun Seung Yu, CEO of CGBio, commented, “The breakthrough device designation for NOVOSIS PUTTY is further proof of CGBio’s technological prowess, innovation, and potential. With the designation’s emphasis on quickly bringing beneficial products to market, we are committed to helping more patients overcome diseases and return to healthy lives through NOVOSIS PUTTY.”

Jumi Han, head of CGBio’s U.S. Development Center, stated, “The ‘Breakthrough Device Designation’ for NOVOSIS PUTTY confirms that regulatory authorities are prioritizing support for our product development. We are accelerating U.S. clinical trials to demonstrate its efficacy and safety.”

According to DelveInsight’s “Spinal Implants Market” report, the global spinal implants market was valued at USD 13.01 billion in 2022, growing at a CAGR of 5.40% during the forecast period from 2023 to 2028 to reach USD 17.84 billion by 2028. The rise in demand for Spinal Implants is predominantly attributed to the increasing prevalence of various spinal disorders which include spinal stenosis, degenerative disc diseases, disc herniation, and others in the older population across the globe. Moreover, shifting focus toward technological advancement in bone graft products, rising awareness among the patient population regarding spinal disorder and their proper management, and rising preferences for minimally invasive surgeries are the factors driving the spinal implant market.

EndoSound® Received 510(k) Clearance for Breakthrough EVS® Innovation, a Novel Endoscopic Ultrasound (EUS) Technology

On January 2, 2024, EndoSound® Inc., a pioneering medical technology company dedicated to advancing patient care, announced that it has received 510(k) clearance from the US FDA for its EndoSound Vision System® (EVS®). 

The EVS developed by EndoSound is a novel endoscopic ultrasound (EUS) that fits on the top of gastrointestinal endoscopes. The device is capable of integrating easily with the current environment of any endoscopic center. Compared to traditional EUS equipment, the EVS can offer more accessibility to this critical imaging and therapeutic technique. EndoSound anticipated that the EVS will shift the site of care to more effective locations, such as ambulatory surgery centers (ASCs), which are favored by payers, providers, and patients.

“We are thrilled to receive 510(k) clearance for our EVS, a testament to the dedication and innovation of the entire EndoSound team. This milestone underscores our commitment to advancing medical technology and improving patient outcomes. With the EVS, we aim to not only enhance the safety of endoscopic procedures but also contribute to expanding access to care for patients worldwide,” said Dr. Stephen Steinberg, President and CEO at EndoSound. 

According to DelveInsight’s “Endoscopic Ultrasound Market” report, the global endoscopic ultrasound market is growing at a CAGR of 5.40% during the forecast period from 2023 to 2028. The rise in demand for Endoscopic Ultrasound systems is predominantly attributed to the increasing prevalence of gastric cancers such as upper and lower gastrointestinal cancers. Moreover, the increase in the incidence of chronic digestive disorders, the increase in investment in R&D activities for the development of novel products, and the rise in the adoption of endoscopy ultrasound techniques are some of the key factors driving the growth of the Endoscopic Ultrasound spinal market.

Boston Scientific Initiated AVANT GUARD Clinical Trial to Evaluate FARAPULSE™ Pulsed Field Ablation System as First-Line Treatment for Persistent Atrial Fibrillation

On December 28, 2023, Boston Scientific Corporation announced that it has initiated the AVANT GUARD clinical trial to evaluate the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System.   

More than 500 patients diagnosed with persistent AF will be enrolled in the AVANT GUARD clinical trial in 75 global sites. Patients during the study will be randomized to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using the FARAPULSE PFA System, or receive AAD treatment, for three years. The experiment will compare the effectiveness of therapy administered via the FARAPULSE PFA System against that of AADs., including device-or procedure-related adverse events, the rates of freedom from AF, atrial flutter, or atrial tachycardia, as well as AF burden – a measurement of the amount of AF an individual experiences. Additionally, the Boston Scientific LUX-DxTM Insertable Cardiac Monitor will also be implanted in every patient during the study. This device is intended to detect the recurrence of cardiac arrhythmias and to measure the burden of AF by providing continuous rhythm monitoring. It also makes the monitoring procedure easier for patients by automatically gathering and transmitting arrhythmia episode data.

“With nearly 40,000 patients treated to date in clinical and commercial settings, the FARAPULSE PFA System continues to demonstrate a promising safety and effectiveness profile, upon which this study seeks to build,” said Dr. Brad Sutton, Chief Medical Officer, of AF Solutions, Boston Scientific. Dr. Brad added, “The AVANT GUARD trial is exciting in that it has the potential to change clinical practice by advancing the therapy to be utilized as an earlier treatment for persistent AF, which may lead to better long-term outcomes and establish the FARAPULSE PFA System as the preferred method for treating the disease.”

According to DelveInsight’s “Ablation Devices Market” report, the global ablation devices market is estimated to grow at a CAGR of 11.65% during the forecast period from 2023 to 2028. Factors such as the increasing incidence of cancers such as liver cancer, the rising prevalence of chronic pains such as musculoskeletal pains, the rising prevalence of cardiac arrhythmias such as atrial fibrillation, and the rising regulatory approvals for technologically advanced ablation devices. Therefore, the market for ablation devices is estimated to grow at a significant CAGR during the forecast period from 2023 to 2028.