TMINI Miniature Robotic System by THINK Surgical Received FDA 510(k) Clearance

On May 30, 2023, THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TMINI™ Miniature Robotic System.

A wireless robotic handpiece that is part of the TMINI system helps surgeons perform total knee replacements. The TMINI robotic handpiece automatically corrects the surgeon’s hand movement to locate bone pins along with precisely defining planes while executing a three-dimensional surgical plan based on a CT scan. TMINI is simple to use and takes the place of many of the current knee replacement surgery tools.

Together with Cambridge, UK-based R&D consultancy Sagentia Innovation, THINK Surgical created the TMINI robotic handpiece. The innovative design of the TMINI robotic handpiece, which is simple for surgeons and staff to incorporate into operating room workflows, was made possible by the combined technical expertise of both companies. 

To maintain its commitment to an open implant library, THINK Surgical will gradually add new implant choices to the platform. Given the simplicity of the TMINI system and the open implant strategy, a large customer base that may have previously been wary of robotics should find interest in the product.

“With its small footprint, open implant platform, and intuitive workflow, the TMINI system opens up robotic possibilities for more clinics, operating rooms, and surgeons,” said Stuart Simpson, president, and chief executive officer of THINK Surgical.

“The broader market opportunity for the TMINI system makes this an important development in surgical robotics. It’s been exciting supporting this project from early concept development through transfer to manufacturing, and we look forward to its commercial success,” said Duncan Smith, managing partner of Sagentia Innovation.

As per DelveInsight’s “Surgical Robotic System Market” report, the global surgical robotic devices market was valued at USD 5.02 billion in 2022, growing at a CAGR of 11.50% during the forecast period from 2023 to 2028 to reach USD 9.64 billion by 2028. The demand for surgical robotic systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as the increasing geriatric population who form a big part of the at-risk population for prostate cancer, endometriosis, valvular diseases, among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the surgical robotic systems market during the forecast period from 2023-2028.

Cepheid’s Xpert NPM1 Mutation Test Received a CE Mark 

On May 30, 2023, US-based molecular diagnostics company Cepheid secured the CE mark for its molecular in vitro diagnostic test, Xpert NPM1 Mutation.

Acute myeloid leukemia (AML) patients‘ peripheral blood samples are used in the test to measure mutant NPM1 mRNA transcripts (types A, B, and D in exon 12).

The test provides the percentage of mutant NPM1 to ABL1 endogenous control mRNA transcripts using automated real-time reverse transcription polymerase chain reaction.

The European Leukemia Net recommends using quantitative molecular assessment of NPM1 through qPCR as part of minimal residual disease monitoring for AML patients with NPM1 mutations. 

The company’s hematology-oncology portfolio, which already includes Xpert BCR-ABL Ultra p190 and Xpert BCR-ABL Ultra, is said to benefit from the addition of the new diagnostic test.

Cepheid oncology medical and scientific Affairs Vice-President Dr. Michael Bates said, “NPM1 mutations are found in approximately one-third of acute myeloid leukemia cases and can be used to monitor response to therapy as well as to predict relapse. The Xpert NPM1 Mutation test quantifies the mRNA transcripts of the A, B, and D mutations accounting for approximately 90% of NPM1 mutant cases, plus the ABL control gene, and provides an easy and convenient method of assessing response to therapy and improving the management of patients with AML.” 

According to DelveInsight’s “In-vitro Diagnostics Market” report, the global in-vitro diagnostics market was valued at USD 71.01 billion in 2022, growing at a CAGR of 4.71% during the forecast period from 2023 to 2028, to reach USD 93.60 billion by 2028. The in vitro diagnostics market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of various infectious diseases such as COVID-19, the growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities concerning in-vitro diagnostics among others. 

Anika Completed Enrollment in Hyalofast® US Pivotal Phase III Study

On May 30, 2023, Anika Therapeutics, Inc., a global joint preservation company focused on early intervention orthopedics, announced the completion of the enrolment of participants for its pivotal Phase III clinical study of Hyalofast, on its path to achieving FDA approval in the United States.

Hyalofast is a highly differentiating, one-stage, hyaluronic acid (HA), matrix that preserves bone. Hyalofast is implanted in one surgery after debridement of the diseased tissue, as opposed to the current standard of care which requires two surgeries including removal of autologous cartilage, cell expansion, and subsequent cell reimplantation at the diseased site, or an alternative product that requires removing healthy bone to accommodate an implant. 

Hyalofast is stocked at the surgical facility and can be easily taken off the shelf during surgery when a cartilage lesion is identified, which lessens the burden on patients and the healthcare system.

Hyalofast is a truly revolutionary treatment for patients with pain and reduced function brought on by cartilage lesions. It is already available in more than 35 countries outside of the United States. The requirement for surgeons to perform and patients to endure a second surgical procedure to use the product currently on the market has restricted the US cartilage repair market. Without the need for a second expensive, invasive surgery, Hyalofast’s off-the-shelf, bone-preserving design enables surgeons to quickly repair lesions intraoperatively.

“This is an important milestone for Anika, bringing us one step closer to making Hyalofast available for patients in the United States,” said Anika’s President and CEO, Cheryl R. Blanchard, Ph.D. “The knee cartilage repair market in the U.S. is large and growing and is perfectly aligned with our strategic focus as we continue to introduce ground-breaking regenerative solutions that expand our Joint Preservation and Restoration portfolio. We believe that Hyalofast will drive significant market expansion and further accelerate our company’s growth in the coming years. We are pleased that FDA has granted Hyalofast Breakthrough Device Designation and has agreed to a modular PMA filing, both of which will facilitate an efficient review process.”

According to DelveInsight’s “Knee Reconstruction Devices Market” report, the global knee reconstruction devices market was valued at USD 7.87 billion in 2022, growing at a CAGR of 4.52% during the forecast period from 2023 to 2028 to reach USD 10.27 billion by 2028. The rise in the demand for knee reconstruction/replacement devices is predominantly attributed to the burgeoning old-age population and the rising prevalence of various knee-associated musculoskeletal disorders such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis, and others. Also, the growing demand for minimally invasive surgeries and various technological advancements to improve the efficiency of the products are key market drivers.

EMVision Initiated the Stage II of the Portable Brain Scanner Trial

On May 30, 2023, the Australia-based EMVision Medical Devices initiated the Stage II of its clinical trial for its first-generation portable brain scanner.

The first phase of the trial has just recently been completed, involving 30 healthy volunteers.

Further, 150 patients with acute strokes and stroke mimics are expected to enroll in the second stage. Major comprehensive stroke centers in Australia, including Royal Melbourne Hospital, Princess Alexandra Hospital, and Liverpool Hospital, are participating in the trial.

Each site has a population of stroke patients and a committed research team to support a quick patient enrolment process.

EMVision Medical Devices CEO Dr. Ron Weinberger said, “Significant preparation and positive collaboration between the EMVision team and hospital staff has been underway to ensure the next phase of our multi-site clinical trials is set up for success. We have taken the technical and usability information from Stage I and refined our device for Stage II and although the modifications are not major, they will result in significant performance improvements.”

According to DelveInsight’s “Neurology Devices Market” report, the global neurology devices market is estimated to grow at a CAGR of 7.46% during the forecast period from 2023 to 2028. The neurology devices market is observing optimistic market growth due to factors such as the rise in the number of regulatory approvals for neurology devices across the globe. Further, the increasing cases of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population coupled with the increasing prevalence of neurological diseases are going to increase the demand for various neurological devices across the globe. Additionally, the growing focus on improving the safety, affordability, and usability of neurology devices for end users is further expected to result in appreciable revenue growth in the neurology devices market during the forecast period (2023-2028).

HeartBeam Entered into Strategic Alliance Agreement with Samsung

On May 30, 2023, HeartBeam, Inc., a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform intended for patient use at home, entered into a Strategic Alliance Agreement (SAA) with Samsung, extending the existing SAA between LIVMOR and Samsung.

Under the terms of the contract, HeartBeam and Samsung will identify and specify opportunities for cooperation, drawing on the knowledge and patented technology of the HeartBeam team in the evaluation and monitoring of cardiac symptoms.

“The goal of this partnership is to bring the standard of care for cardiac diagnostic capabilities to patients by utilizing cutting-edge technologies of both Samsung and HeartBeam,” said Branislav Vajdic, Ph.D., HeartBeam CEO, and Founder. Branislay further added, “Our newly acquired state-of-the-art, FDA-cleared, Samsung watch-based arrhythmia detection tool, once integrated with the HeartBeam AIMIGo™ telehealth platform, presents a unique opportunity to extend our product capabilities well beyond what is currently available for cardiac patients outside of a medical setting.”

Kevin Jones, Senior Director, Federal Healthcare, Samsung Electronics America, added, “The strategic collaboration between Samsung and LIVMOR was very successful, resulting in an FDA-cleared solution for Atrial Fibrillation detection centered around the Samsung Galaxy watch and tablet running Samsung’s defense-grade cyber-security system, Knox. We are excited that LIVMOR is now part of HeartBeam and look forward to continuing our successful collaboration. The potential of combining LIVMOR’s technology and the HeartBeam AIMIGo system holds significant promise to address major cardiac conditions for our veterans.”

According to DelveInsight’s “Cardiac Monitoring Devices Market” report, the global cardiac monitoring devices market is estimated at a CAGR of 5.4% during the forecast period from 2023 to 2028. The demand for cardiac monitoring devices is primarily being boosted by the rising prevalence of cardiovascular diseases, technological advancement in product development, increasing geriatric population, sedentary lifestyle, and increasing awareness programs regarding cardiovascular diseases.

Eosolutions Corp. Announced the Full Commercial Launch of the Dr. Banner Balloon Guide Catheter

On May 24, 2023, EOSolutions Corp., a pioneering medical technology company focused on delivering high-quality catheter solutions, launched Dr. Banner, Balloon Guide Catheter (BGC). 

It was developed in collaboration with InNeuroCo, a leading design, consulting, and contract manufacturing group with Dr. Banner setting new benchmarks in catheter technology, providing physicians with unparalleled capabilities. 

The device offers various features such as the largest inner diameter (ID) of 0.091, improved proximal stability, distal trackability, and a super-compliant polyurethane balloon.

“Dr. Banner marks a significant milestone in the field of neurovascular interventions,” said Anthony Parise, General Manager and Head of Sales & Marketing at EOSolutions Corp. Dr. Banner further added, “With its unparalleled inner diameter, proximal stability, distal trackability, and super compliant polyurethane balloon, Dr. Banner empowers physicians to overcome the challenges of complex anatomies, providing precise and effective treatment options for their patients. We are excited to respond to the needs of our physicians by introducing this ground-breaking catheter that will improve upon their ability to perform the most challenging neurovascular procedures.”

According to 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 the 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 during the forecast period from 2023-2028.