Life Science Intelligence’s Weekly Medtech Pro Review provides a preview of select market data and startups covered in the full Medtech Pro Platform, which is a comprehensive market intelligence solution for medtech executives. As a preview of the types of content found on Medtech Pro, the Weekly Medtech Pro Review will cover select market data, procedure volumes, and startups.
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Medtech Market Snapshot – Implantable CRM Devices
Cardiac rhythm management (CRM) devices are used to correct and manage cardiac arrhythmias. Implantable devices used for the management of arrythmia include pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices. These devices are designed to treat the many different types of arrythmia.
According to market data from LSI, global sales attributable to implantable CRM were approximately $15.5B. Due to the impact of the COVID-19 pandemic on the healthcare system in 2020, a surplus of procedures that were rescheduled or cancelled will be
The market for these devices is projected to increase at a CAGR of 5.2% to $17.0M in 2021. Total product sales are anticipated to see a mild rebound in 2021 in response to slowed growth during the outbreak of the COVID-19 pandemic. Following this rebound, sales of drug delivery devices will stabilize and taper over the next 4 years.
LSI’s analysis of the drug delivery devices market encompasses sales of injection devices, infusion pumps, and related administration sets. It excludes the sales of orally administered therapeutic agents, depot and transdermal drugs, and implantable pain pumps.
For more market data on the global implantable CRM devices market, as well as other medtech markets, visit LSI’s Medtech Pro platform.
Surgical Procedure Volumes – Intracranial SRS in Russia
Life Science Intelligence tracks surgical procedure volumes across 37 countries and 12 major surgical markets (e.g. orthopedics, ENT, aesthetics). This week, our featured surgical procedure volume is for intracranial stereotactic radiosurgery (SRS) procedures in Russia. Stereotactic radiosurgery focuses tiny beams of radiation to create or obliterate a lesion, without requiring open surgery (i.e. surgical incision). The technique is often used as a high precision treatment method for tumors, vascular malformations, and abnormalities of the brain. Types of SRS include charged particle methods, Gamma Knife, and linear accelerators.
According to LSI’s Surgical Procedure Volumes database there were an estimated 4,700 intracranial SRS procedures performed in 2020 in Russia. The country’s response to the COVID-19 pandemic was similar to many other nations, with the Russian government implementing preventative measures to slow the spread of the coronavirus. While SRS is typically considered to be an elective procedure, indications for urgent procedures are easily identified. LSI projects that the impact of COVID-19 on intracranial SRS procedure volumes has thus far been negligible. In 2021, an estimated 5,400 intracranial SRS procedures are anticipated to be performed in Russia. At this time, the impact of the Delta variant on intracranial SRS procedure volumes is believed to be minimal.
AtriAN Medical is developing a next generation solution for the treatment of atrial fibrillation. Current ablation solutions utilize thermal-based techniques to ablate tissue. These techniques can cause damage to surrounding healthy tissues and can fail to completely resolve errant electrical signals over time.
To address the limitations of current techniques, AtriAN Medical is developing a targeted, non-thermal approach that uses micro Pulsed Electrical Fields (mPEF) to ablate neuronal cells in clusters known as ganglionated plexi (GPs). This approach to targeting the hyperactive cells on the exterior surface of the heart, sparing the myocardium. According to AtriAN, their cardioneuroblation technique will be a more precise and gentle option for the millions of adults living with AF.
Figure 1: AtriAN Medical’s mPEF console
In June 2015, AtriAN Medical was selected as one of the 50 startups selected for MedtTech Innovators accelerator program.
AtriAN Medical has raised $2.5M in funding, with the most recent funding round being a Seed round that closed in October 2019.
Limb loss is a serious complication associated with chronic kidney disease, diabetes, and peripheral arterial disease (PAD). Early identification and quantification of progression of microvascular dysfunction is key to preventing loss of limb. Modulim has developed a solution to provide clinicians with a point-of-care assessment of microcirculation that facilitates early intervention of microvascular dysfunction.
The company’s Clarifi system is a noninvasive diagnostic that rapidly assesses and quantifies five hemoglobin biomarkers of oxygenation and perfusion. To achieve this assessment of biomarkers, the Clarifi system utilizes a proprietary optical imaging technique called spatial frequency domain imaging (SFDI). The technique provides a quantitative measurement of tissue oxygen availability, extraction, and saturation using visible and near-infrared light and proprietary computational modeling to quantify hemoglobin distribution and oxygenation.
The Clarifi system received 510(k) clearance from the FDA in July 2018. The company has raised approximately $12M in total funding. According to Modulim, investments in the company have largely supported commercialization of the company’s imaging system.
Figure 2: Modulim’s Clarifi system
The origin of Nectero Medical’s name is the Latin word nectere, which means to bind, connect, interweave. In living up to the company’s namesake, Nectero is developing a proprietary technology to bind and stabilize abdominal aortic aneurysms (AAAs).
According to Nectero, there are currently over one million patients in the US with an AAA at risk of rupture that is unable to be treated with current methods. According to a study of 9,457 in patients in the US, the prevalence of AAA is approximately 3% in adults ages 65 to 75. The slow growing nature of AAAs can make them difficult to detect, thought routine screening (annual or semi-annual imaging) of at-risk adults can help to identify AAAs. Aneurysms at risk of rupture require open or minimally invasive surgery. Endovascular aneurysm repair (EVAR) is the most common technique used today for the treatment of AAA, though the technique has many procedure and device related risks.
Nectero Medical’s Endovascular Aneurysm Stabilization Treatment (EAST) system is a minimally invasive alternative to EVAR. The EAST system is comprised of the Stabilizer Delivery Catheter and proprietary Stabilizer Compound. The Stabilizer Compound is diffused into the aneurysm wall and binds with degraded elastin and collagen, increasing tissue strength and reducing the risk of rupture.
Figure 3: Example of Nectero Medical’s EAST system to treat AAA
Initial clinical experience with the EAST system shows that the procedure can be performed in under an hour, compared to the 3 to 4 hours required to perform EVAR. Due to a device not being implanted, Nectero Medical’s solution avoids the device-based complications associated with current treatment options.
The company has raised over $20M in funding, with Boston Scientific being a major investor in Nectero.