industry news

03 MARCH 2020

Researchers develop complex lab model of human body

Scientists at Wake Forest Institute for Regenerative Medicine (WFIRM) have developed what they claim to be the world’s most sophisticated laboratory model of the human body.

The researchers have created a set of miniaturised organs that can be used to detect adverse effects of drugs before they’re prescribed to patients.

The tiny 3D tissue structures are built from many human cell types combined into tissues and represent a majority of internal organs, including the heart, liver and lungs. They contain blood vessel cells, immune system cells and fibroblasts, and perform the same function they do in the human body.

Another hallmark feature of the WFIRM organ tissue system is the blood circulatory system. Each organ contains media that circulate among all the organ types to deliver oxygen and remove waste, using microfluidics to recirculate test compounds through the organ system and remove the drug breakdown products that each organ is producing.

The microfluidic circuit recirculates drug samples over and over through the organ system in the same way the heart recirculates molecules through the human body.

Despite their small size, at roughly one millionth the size of an adult human organ, the organs have the potential to speed the path of drugs to market, lower the cost of clinical trials and reduce or eliminate animal testing.

WFIRM director Dr Anthony Atala said: “The most important capability of the human organ tissue system is the ability to determine whether or not a drug is toxic to humans very early in development, and its potential use in personalised medicine.”

The miniature organs have been used to measure the toxicity in many drugs approved for human use that were later pulled from the market due to harmful side effects. More than 15 tissue and organ technologies developed by WFIRM scientists have been tested in humans in clinical trials.

Toxicity that has been missed using standard 2D cell culture systems, animal testing models or human clinical trials has been detected and replicated by the WFIRM 3D organ system.

Atala said: “Weeding out problematic drugs early in the development or therapy process can literally save billions of dollars and potentially save lives.”

03 MARCH 2020

SAM Medical introduces SAM IO Intraosseous Access System

SAM Medical, a medical device company focused on the development of trauma care equipment, has launched a SAM IO Intraosseous Access System for pre-hospital and hospital healthcare providers.

The manually-powered device is designed as an intuitive alternative solution to intraosseous access. These multi-use drivers enable clinicians to easily administer critical fluids and medications into patients’ vascular system through the bone marrow during emergencies.

SAM Medical president Randy Reed said: “At SAM Medical, we are dedicated to bringing emergency medical professionals the most cutting-edge, innovative and easy to use trauma care devices.

“With the launch of the SAM IO, we are excited to offer a user-friendly, cost-conscious and more reliable option for providing quick and safe access to a patient’s vascular system when an IV is not feasible.”

SAM IO comprises a driver and a needle assembly. The needle assembly, including a stylet and catheter, is fixed to the driver through a snap-fit design, released through the soft tissue of either proximal humerus, distal tibia, distal femur (paediatrics only) or proximal tibia.

Once the needle tip touches the bone, the driver handle actuates, producing rotational control of the needle assembly. The cutting flutes of the catheter pierce through cortical bone until the needle assembly is introduced into the bone marrow. The driver and stylet are then detached from the catheter.

The system has secured US Food and Drug Administration approval and is now available in the US.

The company expects to expand its sales worldwide as soon as the system secures market registration in other countries.

03 MARCH 2020

Insulet to pause pivotal study on automated glucose control system

02 MARCH 2020

PerkinElmer selected as provider for SCID evaluation programme

US-based PerkinElmer has been selected as a provider of newborn screening test for Public Health England’s Severe Combined Immunodeficiency (SCID) evaluation programme.

The company will provide Public Health England with its VICTOR EnLite instrument and EnLite Neonatal TREC Kit to screen newborn babies at three of six sites as part of the programme.

SCID, also known as ‘Bubble Boy’ disease, is a rare inherited genetic condition caused by a severe defect in the immune system, making it hard or impossible to resist infections.

Although the condition is treatable, it can be fatal if it is not diagnosed in newborns before the symptoms appear.

Treatments include stem cell transplants using cells procured from a family member or donor.

PerkinElmer reproductive health general manager Petra Furu said: “Our collaboration with Public Health England underscores our global market leadership in offering an expansive menu of innovative newborn screening solutions for a wide range of rare conditions for more than 30 years.

“This programme will evaluate the potential to provide widespread access to SCID screening for newborn babies throughout England, helping to ensure timely treatment for a disease that may otherwise go undetected for years and giving babies a better chance at improved health outcomes.”

PerkinElmer’s VICTOR EnLite instrument and EnLite Neonatal TREC Kit enable an effective, semi-quantitative determination of T-cell receptor excision circle (TREC).

TREC, a circular DNA structure, is the primary identifiable marker for SCID.

The test provides precise results that can help identify newborns for confirmatory testing, which leads to a diagnosis. The kit workflow, as compared to current laboratory tests, has less manual work involved and is less time-consuming.

Furthermore, PerkinElmer’s extensive newborn screening menu consists of tests for more than 50 recommended conditions.

In October, the company also introduced PG-Seq Rapid non-invasive preimplantation genetic testing for aneuploidy (PGT-A) kit.

28 FEBRUARY 2020

Ra Medical System enrols first patient for atherectomy clinical trial

Ra Medical Systems, a medical device company, has enrolled the first patient in its study to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device to treat peripheral vascular stenosis.

DABRA is a minimally-invasive excimer laser system used by physicians as a tool in the endovascular treatment of vascular blockages caused by lower extremity vascular disease.

Earlier in January, the company secured the US Food and Drug Administration (FDA) clearance to begin investigational device exemption (IDE) for the study.

Ra Medical Systems CFO and Interim CEO Andrew Jackson said: “We are committed to the successful commercialisation of DABRA and we believe that initiating patient enrollment in this study is a significant step forward in achieving this goal.

“Furthermore, we have built a team of experienced, motivated and enthusiastic physician partners and employees to execute on this goal and we look forward to providing updates on our progress.”

The company expects to enrol 100 patients with symptoms of PAD (Rutherford Class 2-4) for the multicentre, open-label pivotal atherectomy clinical study.

Athar Ansari, MD, FACC, director of the California Heart & Vascular Clinic in El Centro said: “My extensive experience with DABRA in treating infrainguinal vascular occlusions gives me confidence in the safety and efficacy of the device.

“We are thrilled to be the first centre to begin enrolment in the atherectomy study, which represents an important next step in expanding the DABRA indications for use.”

Outcome measures of the trial include safety, acute technical success and clinical success.

The primary efficacy endpoint is the mean decrease in per cent diameter stenosis in each patient’s primary lesion measured by angiography immediately after treatment with DABRA, before any adjunctive treatment.

The safety and clinical success endpoints feature major adverse events at 30 days and incidence of primary target lesion revascularization (TLR) at six months.

Ra Medical Systems sells excimer lasers and catheters to treat dermatological and vascular diseases.

27 FEBRUARY 2020

Gore Innovation Center collaborates with startup Moray Medicals

US-based Gore Innovation Center has announced a collaboration with robotics startup Moray Medicals to improve its minimally invasive interventional medical procedures.

Founded by Mark Barrish and Phillip Laby, Moray Medical is a two-year-old startup. It focuses on designing an automated delivery system for endovascular procedures.

The robotic cardiac catheter system developed by the startup delivers therapies with increased precision. The system, which does not use pull wires, magnets, or motors, relies solely on computer-controlled microfluidic pressure.

In 2019, Moray Medical was named as a Roseman Innovator by UCSF Rosenman Institute for its innovative technology and patient impact.

Previously, Gore Innovation Center prototyping lab allowed Moray Medicals to test, build and enhance its catheter system. Now, it offers the startup its broad testing and manufacturing capabilities to aid transformative breakthroughs.

Moray Medical co-founder Phillip Laby said: “The Gore Innovation Center offers deep engineering expertise and foundational capabilities that have helped us drive our idea forward. We have made significant advancements on bringing robotic dexterity, precision and ease-of-use to a range of therapies.”

Gore Innovation Center, founded by materials science company Gore, provides startups with the opportunity to build and test their technologies.

Gore Innovation Center leader Linda Elkins said: “Combining deep materials science expertise with market insights, the Gore Innovation Center helps startups accelerate their technology development.

“Gore materials are a core component for many everyday products. Our scientists can independently alter specific material attributes such as microstructure, thickness, modulus, and form factor to achieve desired performance in a variety of applications.”

Meanwhile, Gore has invited Silicon Valley startups working on breakthroughs in sustainable technologies and advanced materials to apply for workspace through 31 March.

26 FEBRUARY 2020

Janssen and Apple launch Heartline study

26 FEBRUARY 2020

Cynosure secures FDA clearance for RF microneedling device

Cynosure, a US-based medical device company focused on medical aesthetics, has received regulatory clearance from the US Food and Drug Administration (FDA) for its radiofrequency (RF) microneedling device Potenza.

The device is intended for electrocoagulation and haemostasis of soft tissue for dermatologic conditions.

Claimed to be only FDA-cleared four-mode RF microneedling device, Potenza allows clinicians to offer patients customised treatments.

The device can be used in monopolar mode and bipolar mode at either 1MHz or 2MHz frequency.

Monopolar RF mode releases energy across a significant area of tissue for deep heating and skin tightening through soft tissue coagulation. Bipolar RF mode provides a concentrated delivery of power to treat superficial tissue to give skin revitalisation results.

The device features Tiger Tip technology, equipped with a single-needle handpiece intended to target and improve blemishes.

Cynosure CEO Todd Tillemans said: “Our goal at Cynosure is to provide our customers with revolutionary technologies so they can consistently deliver outstanding results.

“Potenza takes the microneedling category to a new level by offering unprecedented flexibility for doctors, which translates to personalised treatments and satisfied patients with exceptional outcomes.”

Potenza treatments combine ultrafine needles and radiofrequency energy to penetrate the skin’s top layer and stimulate the body’s natural healing process to regenerate collagen and elastin.

Cynosure claim that the Potenza treatments can perform on all skin types and all body parts.