Boston Scientific to acquire majority stake in Acotec Scientific for $523m
12 December | Deals
Boston Scientific announced that it will make a partial offer to buy a majority stake of up to 65% in Chinese medical technology firm Acotec Scientific for around $523m. Acotec Scientific develops medical devices, including drug-coated balloons (DCB) and percutaneous transluminal angioplasty balloon catheters (PTA), which are mainly used to treat vascular interventions.
The company has a complete DCB product portfolio with five therapeutic area targets, including neurology, cardiology, nephrology, andrology, and vascular surgery. Following the receipt of National Medical Products Administration approval, Acotec Scientific introduced the first peripheral DCB in China in 2016.
The company’s portfolio includes thrombus aspiration catheters and radiofrequency ablation technologies, along with more than 20 other products across different specialties in various development stages. Boston Scientific MedSurg and Asia Pacific group president and executive vice-president Art Butcher said: “Acotec is a profitable, fast-growing company with a strong portfolio and innovative pipeline of medical technologies, and we believe this investment will generate growth opportunities for both companies.
“We expect completion of the partial offer to further strengthen our presence in China and create the potential for commercialisation of Acotec products globally, providing an increased number of physicians and patients access to our robust and complementary product portfolios.”
Main image: Boston Scientific, Silicon Valley. Credit: Sundry Photography/ Shutterstock
9 December| Deals
Tandem Diabetes Care to acquire AMF Medical
Tandem Diabetes Care signed a definitive agreement to buy Swiss medical equipment manufacturer AMF Medical.
Under the deal terms, Tandem Diabetes Care will make a cash payment of $66.9m (Sfr62.4m) upon closing, in addition to a previous $8.57m (Sfr8m) strategic investment made in the third quarter of the year. Additionally, Tandem Diabetes Care will make earnout payments of up to $138.9m (Sfr129.6m) upon achieving certain milestones.
AMF Medical is currently developing the Sigi Patch Pump, which has been designed for diabetes mellitus treatment. Sigi has been designed as an ergonomic, rechargeable patch pump for reducing the burden of managing diabetes. It works with readily available pre-filled insulin cartridges and can be controlled directly through the user’s personal smartphone.
The insulin patch pump also offers compatibility with automated insulin delivery technology. It received breakthrough device designation from the US Food and Drug Administration (FDA) last November. Tandem Diabetes Care stated that AMF Medical’s insulin delivery solution expands its market opportunities for both type 1 and 2 diabetes.
7 December | Approvals
Activ Surgical’s imaging system receives CE Mark approval
Activ Surgical has announced receipt of CE Mark approval for its enhanced imaging system, ActivSight Intelligent Light.
The approval of the easy-to-adapt module validates that it meets the requirements of the European Medical Devices Regulation. Activ Surgical will now be able to commercialise ActivSight across the European Union and other regions where the CE Mark is required.
Designed to be a routine part of surgical practice, ActivSight attaches to existing laparoscopic systems and provides on-demand, real-time surgical insights. It is said to be the first and only modular form factor with multimodal advanced visualisation for surgeries that are minimally invasive.
A hardware-agnostic module, ActivSight provides surgeons with critical intraoperative visual data and imaging to help improve patient safety and outcomes in the operating room. Activ Surgical CEO Todd Usen said: “The team at Activ Surgical is thrilled to achieve the CE Mark for ActivSight in the European Union and beyond.
“This clearance represents a momentous step forward for the company as we execute against our global commercialisation strategy for the system. “We believe ActivSight will be a game-changer in the operating room by revolutionising surgical vision and, ultimately, improving surgical care and patient safety.”
20 December | Approvals
US FDA approves Abbott’s Eterna spinal cord stimulation system
The US Food and Drug Administration (FDA) has granted approval for Abbott’s Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain. The Eterna SCS system is said to be the smallest implantable, rechargeable system which is currently available on the market for this indication.
It uses the company’s low-dose BurstDR stimulation, the SCS waveform technology that mimics the natural firing patterns which are found in the brain to provide superior pain relief. The company stated that the SCS technology has shown 23% more pain reduction compared to traditional waveform technology approaches. It also noted that the Eterna SCS system has been developed based on extensive studies conducted with patients, physicians, and caregivers for understanding the unmet requirements of chronic pain patients.
The studies found that people preferred a smaller implant, with a reduced need to charge the device daily or weekly. Eterna SCS system can be wirelessly charged less than five times a year under normal use, which is said to be the lowest recharge burden compared to other SCS systems.
Abbott neuromodulation vice-president Pedro Malha said: “At Abbott, we deliver products and solutions with the goal of simplifying healthcare, improving clinical outcomes, and providing people suffering from chronic pain with the best experience possible. As we progress on this commitment, Eterna is the next major leap forward.
“Eterna is the smallest rechargeable spinal cord stimulator on the market, provides the longest therapy between charges and offers an optimised recharging experience – all key features when selecting the best overall system.”
The company said that the new neuromodulation device uses its TotalScan MRI technology that allows for full-body MRI scans for chronic pain patients who need improved diagnostics and healthcare.
Additionally, its patient-focused mobile app displays real-time battery life and charging status updates of the Eterna SCS system on a personal or Abbott-provided dedicated Apple device.
16 December | Trials
Medtronic enrols first subject in Hugo RAS system trial
Medtronic has enrolled the first participant in the Expand URO US clinical trial of the Hugo robotic-assisted surgery (RAS) system. Dr Michael Abern has performed the robotic-assisted prostatectomy procedure at Duke University Hospital in Durham, North Carolina.
The single-arm, prospective, multi-centre Expand URO trial will assess the performance and safety of the Hugo RAS system for urologic procedures. The Hugo RAS system has been designed to reduce the ownership total cost and optimise system utilisation. It is a modular and portable platform that can be moved between ORs and configure to fit both patient and procedure.
In the study, Hugo RAS system is intended to be utilised for urologic surgical procedures that include radical cystectomy, nephrectomy (partial or radical), and radical prostatectomy procedures at sites in the US. The Expand URO clinical trial will enrol 122 patients at six sites in the country.
The company stated that the study is being conducted according to an Investigational Device Exemption received from the US Food and Drug Administration (FDA).
14 December | Trials
GIE Medical begins two clinical trials of drug-coated balloon technology
GIE Medical has launched two clinical trials in the US to investigate the use of ProTractX3 TTS DCB, its multi-stage drug-coated balloon (DCB) technology, in oesophagal and bowel strictures.
The first multicentre randomised controlled clinical trial, dubbed PAclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture – Esophagus (PATENT-E), has been designed to assess the efficacy and safety of the DCB technology to treat benign oesophagal strictures. In the trial, participants will be randomised to receive either ProTractX3 DCB or standard-of-care endoscopic dilation.
It will compare the participants who have improvement of dysphagia symptoms without clinically driven repeat intervention at six months after treatment. Additionally, the study will compare the rate of treatment-related major adverse incidents that occur within 30 days of the treatment. The company stated that its investigational ProTractX3 3-Stage TTS DCB is coated with paclitaxel, a chemotherapeutic agent. GIE Medical chief operating officer Peter Barnett said: “This technology could truly impact patient care and quality of life, and our initial use cases mark the first time this groundbreaking technology has been used in the United States.”
16 December | Deals
Anumana and Pfizer partner for cardiovascular disease detection
Health technology company Anumana and Pfizer have signed a multi-year agreement to develop an artificial intelligence electrocardiogram (AI-ECG) algorithm for the early detection of cardiac amyloidosis. Under the deal, Anumana will carry out a clinical validation trial and seek De Novo classification for the new AI-ECG algorithm as a Software-as-a-Medical-Device (SaMD).
The new AI-ECG algorithm will be designed for detecting patients who may be at risk of cardiac amyloidosis, which is a progressive, and underdiagnosed rare disease that leads to heart failure.
Anumana will also obtain regulatory approval for the algorithm as a SaMD to detect cardiac amyloidosis in Europe, Japan, and the US. Anumana chief business officer David McMullin said: “The challenge in diagnosing cardiac amyloidosis can prevent patients from getting treatment while the disease continues to progress.
“We believe this collaboration will demonstrate the power of Anumana’s AI-ECG algorithms to help clinicians intervene earlier, giving them greater ability to improve patient outcomes and prolong lives.”
The company stated that the research deal with Pfizer will help deepen its efforts in implementing AI-enabled early detection software, which can help in revealing the signals from ECGs that cannot be interpreted by humans.
ICR researchers develop new tool to predict prostate cancer risk
Researchers at the Institute of Cancer Research (ICR), London, UK, and the University of Cambridge have developed a new tool to predict the risk of developing prostate cancer in men. The new tool, named CanRisk-Prostate, is already in use by healthcare specialists for predicting the risk of developing breast and ovarian cancers across the world.
It helps to reduce unnecessary and potentially invasive testing for people who are at very low risk of developing the disease. The first comprehensive prostate cancer model was developed using the information on genetic and cancer family history obtained from approximately 17,000 families affected by prostate cancer.
To predict future risks, the model makes use of the rare genetic faults in moderate-to-high-risk genes as well as a risk score based on 268 other common low-risk variants and detailed family cancer histories. Researchers found that the predicted risk of developing the disease was higher for men whose fathers had been diagnosed with prostate cancer, which is 42% if the father was diagnosed at 50 years and 27% if diagnosed at 80 years.
Lipogems raises funds for FDA-approved knee OA studies
Medical technology company Lipogems has raised €12.5m in growth capital this year for its knee osteoarthritis (OA) investigational device exemption (IDE) studies, which were approved by the US Food and Drug Administration (FDA).
These FDA studies are related to a separate and specific indication in knee OA. Lipogems is securing financial resources from ABC Medtech and LIFTT to pave the pathway for a knee OA indication and reimbursement in the US besides building infrastructure to support growth. The funds will also help educate and raise awareness among consumers and patients about knee OA, and extend into other markets with common conditions that have limited therapeutic options and where MicroFat can deliver better relief.
Novosound, PAVmed partner for ultrasound technology
Novosound has entered into a commercial partnership agreement with medical technology company Pavmed to advance intravascular imaging technology. The company stated that the new deal furthers its move into healthcare, as well as its regional expansion into North America.
It is specialised in designing and producing ultrasound sensors using a thin-film technique to address the conventional ultrasound limitations. The company uses its in-house design and manufacturing capabilities in engineering a thin-film core material which is lightweight, compact, extreme temperature resistant, flexible, low profile, and also capable of producing high resolution images.
Novosound CEO and co-founder Dave Hughes said: “PAVmed has a strong track record in delivering commercial stage medical technology across medical devices, diagnostics, and digital health – the group is the ideal partner for Novosound as we increasingly gain traction in the international healthcare sector.”
Recently, the company secured $4.49m (£3.7m) in a financing round, which was led by investment services provider Par Equity.
Cochlear and Oticon Medical merger could result in higher prices, says CMA
The UK’s Competition and Markets Authority (CMA) has announced that the merger of two major hearing implant providers, Cochlear and Oticon Medical, may lead to higher prices for the National Health Service (NHS). The deal could also lead to reduced quality as well as impact innovation for UK patients who depend on these devices.
In April, Cochlear agreed to acquire Oticon Medical, the hearing implant division of Demant, for kr850m ($119.8m). According to the CMA, Cochlear’s proposed acquisition would create a negative impact on patients requiring implants, most of whom purchase their devices through the NHS. Both Cochlear and Demant are involved in the supply of cochlear implants and bone conduction solutions, which are surgically implanted.
Click secures Breakthrough designation from FDA for CT-132 to treat migraine
Click Therapeutics has secured Breakthrough Device Designation for its CT-132 prescription digital therapeutic to treat episodic migraine, from the US Food and Drug Administration (FDA).
CT-132 is currently under development as an adjunctive preventive treatment for episodic migraine in people of age 18 years and above. It has been designed for reducing the number of migraines that occur per month in patients suffering with four or more migraine days per month.
CT-132 combines the company’s adaptive patient engagement platform with multiple clinically validated mechanisms of action. Click Therapeutics chief strategy officer Austin Speier said: “We are thrilled to receive this Breakthrough designation as it will facilitate collaborative discussions with the FDA and help expedite the process of bringing a first-in-class migraine digital therapeutic to patients.
“This is also powerful recognition of the innovative work led by our in-house science and development teams to create a new approach to treating migraine, one supported by early, promising clinical data.” The company stated that the CT-132 programme is authorised by the active support of its Migraine Advisory Board.