Carl Zeiss Meditec AG Completed Acquisition of Dutch Ophthalmic Research Center (D.O.R.C); Companies Unite to Shape Ophthalmology Market 

On April 04, 2024, Carl Zeiss Meditec AG announced that it acquired D.O.R.C. (Dutch Ophthalmic Research Center) from the investment firm Eurazeo SE, Paris, France. The main objective of the acquisition was to enrich ZEISS Medical Technology’s extensive ophthalmic portfolio and suite of digitally interconnected workflow solutions designed to tackle a diverse array of eye ailments, including retina and cornea disorders, cataracts, glaucoma, and refractive errors.

As a prominent figure in the retina surgical devices and consumables market, D.O.R.C. plays a crucial role in shaping the long-term strategy and success of ZEISS Medical Technology. With the inclusion of D.O.R.C., ZEISS gains a distinct advantage, offering an unparalleled array of cutting-edge technologies to ophthalmologists. This includes an expanded, digitally-connected Retina Surgery Workflow from ZEISS. The synergies between the companies’ portfolios are remarkable, and the potent amalgamation of the EVA NEXUS® platform from D.O.R.C. with ZEISS’s comprehensive suite of visualization, diagnostic, and therapeutic devices, along with surgical instruments and consumables, all integrated into a digital ecosystem, will facilitate the development of efficient clinical workflows. This collaboration promises to redefine the ophthalmology market, benefitting surgeons and patients alike.

“Together we are better. Today holds significant importance for us as we bring our teams together and turn our collective attention toward delivering breakthrough innovations and solutions for our customers. We are very excited to welcome D.O.R.C.’s team members to our ZEISS family and to begin integrating our products and practices as we work toward a brighter future together,” says Dr. Markus Weber, President and CEO of Carl Zeiss Meditec AG.

“Together we can offer an unmatched portfolio of advanced technologies and digital workflows. With D.O.R.C., we have an incredible opportunity to serve ophthalmologists around the world with more complete workflows and solutions than ever before,” says Euan S. Thomson, Ph.D., President of Ophthalmology and Head of the Digital Business Unit for ZEISS Medical Technology. “We’ve set our sights high to become the top player in the world for ophthalmology by leveraging our workflow solutions, enhancing our portfolio offerings and market position in the anterior surgery segment, and by significantly expanding our presence in the posterior surgery segment.”

“Together we are stronger. With four decades behind our amazing business and surgeon-inspired innovation, we look forward to writing the next chapter of our success story together with ZEISS Medical Technology,” says Pierre Billardon, CEO of D.O.R.C. “By joining forces, we can extend our reach, scale our efforts, and accelerate ophthalmic surgery advancements for more surgeons faster than before. I am filled with a great sense of pride and gratitude for every D.O.R.C. team member. Together, we have achieved so much to arrive at this pivotal moment in our journey. And together with ZEISS, we have so much more to accomplish in our bright future ahead to help patients see again.”

As per DelveInsight’s Ophthalmic Devices Market Report, the global Ophthalmic Devices Market was valued at USD 55.91 billion in 2023, growing at a CAGR of 4.12% during the forecast period from 2024 to 2030 to reach USD 71.23 billion by 2030. The demand for ophthalmic devices is primarily being boosted by the rising prevalence of myopia and growing geriatric population base which has resulted in the increased prevalence of ocular diseases of different etiologies, increasing number of ophthalmic surgeries, and technical innovation in product development which are expected to increase in the product demand thereby contributing in the growth of the ophthalmic devices market during the forecast period from 2024-2030.

Johnson & Johnson to Acquire Shockwave Medical 

On April 05, 2024, Johnson & Johnson and Shockwave Medical, Inc. announced that they entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired. The transaction was approved by both companies’ boards of directors.

Johnson & Johnson MedTech is strengthening its position in cardiovascular healthcare by acquiring Shockwave, a move that taps into the fast-growing global market for cardiovascular interventions. This expansion targets areas with high patient demand and significant innovation potential. With the addition of Shockwave, Johnson & Johnson broadens its cardiovascular portfolio to include treatments for coronary artery disease (CAD) and peripheral artery disease (PAD), which are among the most promising segments in cardiovascular intervention. This acquisition builds on Johnson & Johnson’s previous successes in acquiring Abiomed and Laminar, enhancing its capabilities in heart recovery and treating atrial fibrillation (AFib). With these strategic moves, Johnson & Johnson MedTech solidifies its leadership across four key cardiovascular segments, reinforcing its commitment to advancing patient care in this rapidly evolving field.

Shockwave is a leading and have advantage of first-to-market provider of innovative intravascular lithotripsy (IVL) technology for the treatment of calcified CAD and PAD. IVL is a minimally invasive, catheter-based treatment for calcified arterial lesions, which can reduce blood flow and cause pain or heart attack. IVL helps restore blood flow by cracking calcium lesions using sonic pressure waves and is used in both CAD and PAD, often in combination with stenting. Shockwave offers the only commercially available IVL technology and has safely, simply, and effectively treated approximately 400,000 patients globally. In addition to its leading IVL platform, Shockwave also recently acquired Neovasc Inc., a company that has developed the Reducer System, a novel product focused on symptom relief of refractory angina. The Reducer System has a growing commercial presence. Right now, it is currently undergoing clinical studies in the U.S. and is CE marked in the European Union and the United Kingdom.

Joaquin Duato, Chairman and Chief Executive Officer of Johnson & Johnson, said, “With our focus on Innovative Medicine and MedTech, Johnson & Johnson has a long history of tackling cardiovascular disease – the leading cause of death globally. The acquisition of Shockwave and its leading IVL technology provides a unique opportunity to accelerate our impact in cardiovascular intervention and drive greater value for patients, shareholders and health systems.”

Tim Schmid, Executive Vice President and Worldwide Chairman of Johnson & Johnson MedTech, said, “Shockwave offers a truly differentiated opportunity to further enhance our leadership position in MedTech, expand into additional high-growth segments, and ultimately transform the future of cardiovascular treatment. Shockwave’s IVL technology for treating CAD and PAD, and its strong pipeline, are in a class of their own. We look forward to bringing Shockwave’s solutions into Johnson & Johnson MedTech and the hands of more physicians around the world.”

According to DelveInsight’s Cardiovascular Imaging Equipment Market Report, the global cardiovascular imaging equipment market is expected to grow at a CAGR of 6.05% during the forecast period from 2024 to 2030. The demand for cardiovascular imaging equipment is primarily motivated by the rising burden of cardiovascular diseases, the increasing number of risk factors associated with cardiovascular diseases, the introduction of technologically advanced systems, and others during the forecast period.

FDA Approved TriClip for Tricuspid Heart Valve Disease, pitting Abbott against Edwards

On April 02, 2024, Abbott announced that the U.S. Food and Drug Administration (FDA) approved the company’s first-of-its-kind TriClip™ transcatheter edge-to-edge repair (TEER) system.

The device is specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve. This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of TriClip outweighed the risks.

As part of its approval process, the FDA reviewed findings from the TRILUMINATE Pivotal trial, the world’s first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery. In the study, 90% of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction that was sustained at one year. The trial also demonstrated a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life.

TriClip leverages the same clip-based technology as Abbott’s leading MitraClip™ device, which has treated more than 200,000 people with leaky mitral valves (mitral regurgitation), but was specifically designed to treat the tricuspid valve’s complex anatomy.

TriClip has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020. The device has already been used to treat more than 10,000 people with TR.

“The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues,” said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE™ Pivotal trial. “With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker.”

“This approval helps address a treatment gap for people with tricuspid regurgitation who previously had few options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business. “With the addition of TriClip to our broad structural heart therapy offerings in the U.S., we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions.”

According to DelveInsight’s Transcatheter Heart Valve Replacement Devices Market Report, the global transcatheter heart valve replacement market is estimated to grow at a CAGR of 13.75% during the forecast period from 2024 to 2030. The transcatheter heart valve replacement market is observing significant market growth primarily owing to the growing number of valvular heart diseases, and aortic stenosis disorders across the globe. Further, the rising focus on minimally invasive surgeries, increasing technological advancements in device & surgical procedures, the increasing burden of the geriatric population prone to aortic stenosis, mitral regurgitation, and other cardiovascular disorders, increasing burden of risk factors leading to valvular diseases, presence of a large number of devices in the pipeline, increasing product launches and approvals, surging investments by key players, among others will ultimately affect the demand for transcatheter heart valve during the forecast period from 2024-2030 growing at a substantial CAGR.

Abbott Received FDA Clearance for Whole Blood Rapid Test to Help with Assessment of Concussion at the Patient’s Bedside

On April 01, 2024, Abbott’s i-STAT TBI cartridge received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient’s bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.

A portable device can now conduct a whole blood test, aiding doctors in assessing adults aged 18 and above who may have suffered mild traumatic brain injury (mTBI), often referred to as concussion. These test results can assist doctors in deciding whether a CT scan of the head is necessary and guide them in planning the most suitable treatment for the patient. Since this test can be done using just a blood sample, it can be performed in healthcare facilities that lack a laboratory, thereby speeding up the evaluation of head injuries.

With this clearance, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, an important advancement since those injured often wait before seeking care.

“Emergency departments can be a busy place. It’s important to be able to triage patients quickly,” said Geoffrey Manley, M.D., PhD, Chief of Neurosurgery at Zuckerberg San Francisco General Hospital, Professor of Neurosurgery at the University of California San Francisco and contact principal investigator for the TRACK-TBI Network. “Historically, that process for suspected concussions was largely subjective. With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care. It’s an incredibly helpful tool that advances the treatment of traumatic brain injury.” 

According to DelveInsight’s Blood Collection Devices Market Report, the global blood collection devices market was valued at USD 6.23 billion in 2023, growing at a CAGR of 6.85% during the forecast period from 2024 to 2030 to reach USD 9.25 billion by 2030. The blood collection devices market is slated to witness prosperity owing to factors such as increase in diagnostic tests owing to the growing prevalence of infectious diseases such as COVID-19, malaria, and others, increasing awareness over health, rise in blood transfusion procedures, and the growing focus on improving the safety and usability of blood collection devices for end users are further expected to result in the appreciable revenue growth in the blood collection devices market during the forecast period (2024-2030).

Biora Therapeutics Achieved Positive Interim Results for Clinical Trial of BT-600, Advancing NaviCap™ Platform Development

On April 04, 2024, Biora Therapeutics, Inc., the biotech company that is reimagining therapeutic delivery, shared additional positive interim results from the single-ascending dose (SAD) clinical trial of BT-600, which is a drug-device combination consisting of the orally administered NaviCap™ device that delivers a proprietary liquid formulation of tofacitinib to the colon. BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC). The SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants.

According to the interim clinical data, all pharmacokinetic endpoints were met in all study participants. BT-600 was well tolerated with no serious adverse events. All devices performed as intended, with all participants receiving BT-600 showing systemic drug absorption. Tofacitinib was first detected in plasma at approximately six hours following administration, which is consistent with colonic delivery as opposed to absorption in the upper GI tract. The mean time to reach maximum concentration (Tmax) was 8–10 hours following administration of BT-600, versus 0.5-1.0 hours for conventional oral tofacitinib. Tofacitinib was present in fecal samples of all subjects, further confirming delivery of the drug in the colon.

Colonic delivery of BT-600 was associated with 3–4x lower systemic absorption of tofacitinib, with a maximum plasma concentration (Cmax) of 26 ng/mL for BT-600 at the 10 mg dose of tofacitinib, versus 88 ng/mL for conventionally administered oral tofacitinib at a 10 mg dose.

“We are extremely pleased with the interim trial results, some of which we shared during our recent quarterly call, that demonstrate the NaviCap platform’s unique ability to achieve localized delivery to the colon, with a corresponding reduction in systemic drug exposure,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “Direct delivery of JAK inhibitors to the colon has potential for improved efficacy driven by increased colonic tissue exposure, while reducing toxicity risks related to systemic exposure. We believe this could lead to better outcomes for patients suffering from UC.”

“Many IBD drugs could benefit from localized delivery—research shows that for JAK inhibitors, integrin inhibitors and TNF inhibitors, higher colon tissue concentrations correlate with better outcomes,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “Our NaviCap platform represents a new therapeutic approach to UC and beyond. We continue to demonstrate that our localized delivery technology can enable higher colon tissue concentrations, without subjecting patients to high systemic drug levels, and results from the SAD portion of our clinical trial further confirm the platform’s capability.”

According to DelveInsight’s Anastomosis Device Market Report”, the global anastomosis device market is estimated to grow at a CAGR of 5.3% during the forecast period from 2024 to 2030. The anastomosis device market is observing remarkable market growth primarily due to the increasing number of coronary bypass graft surgery (CABG) and Ileocolic anastomosis. Further, the rising prevalence of coronary disease, gastric disease, and chronic kidney disease, the increasing technological advancements in the device, the up-surging burden of elderly patients, the increasing product launches, approvals, and others will create a necessity for the anastomosis device in the market. Therefore, the market for anastomosis devices is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.

Medtronic Showed Positive Data For Single-Shot Mapping Ablation Catheter

On April 08, 2024, Medtronic plc announced positive clinical trial safety and efficacy results for Sphere-360™, an investigational single-shot mapping and ablation catheter using pulsed field (PF) energy, for treatment of patients with paroxysmal atrial fibrillation (AFib). Interim findings from the first-in-human Sphere-360 study were presented as a late-breaking clinical trial at the European Heart Rhythm Association (EHRA) 2024 Annual Meeting.

The device is designed with the goal to simplify the AFib procedure while enhancing efficiency and providing high lesion durability, the Sphere-360 catheter features a large, tissue-conformable lattice tip for energy delivery. It requires no need to rotate the catheter multiple times in one location as the entire lattice tip delivers PF energy.

Medtronic also integrated the technology with its Affera mapping and ablation system. The Affera technology makes up a key component of Medtronic’s PulseSelect PFA system, which became the first such system FDA-cleared for treating AFib late last year. Integration offers complete visualization inside the heart and electroanatomical mapping.

Medtronic says its system seamlessly adjusts to various shapes to accommodate different pulmonary vein anatomies. The technology offers real-time local impedance information to assess catheter proximity to tissue. Its over-the-wire design helps with ease of positioning in the vein and streamlined workflow. The system also has compatibility with a small 8.5Fr sheath.

Dr. Vivek Reddy, director of cardiac arrhythmia services at the Icahn School of Medicine at Mount Sinai served as primary investigator. Reddy said the results showed Sphere-360’s potential to become “an important part of next-generation AFib care.”

“We have a vision to continually innovate and bring the best technology to AFib patients around the world, driven by our unwavering commitment to maximizing the safety and efficacy of our products,” said Dr. Khaldoun Tarakji, VP and chief medical officer of Medtronic Cardiac Ablation Solutions. “We are thrilled that the Sphere-360 study results validate our dedication to this goal: an all-in-one single shot mapping and pulsed field ablation catheter, that is fully integrated with the Affera mapping and ablation system, with a unique design that can conform to any pulmonary vein anatomy and can be used with an 8.5Fr sheath, single transeptal access and zero exchange. All these features make the procedure efficient and outcomes more predictable. We can’t wait for what’s next.”

According to DelveInsight’s Balloon Catheters Market Report”, the global balloon catheters market was valued at USD 4.60 billion in 2023, growing at a CAGR of 8.78% during the forecast period from 2024 to 2030 to reach USD 7.62 billion by 2030. 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.