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 – Drug Delivery Devices

Drug delivery devices are designed for the targeted delivery of therapeutic agents to improve the efficacy of medications and biologics, while mitigating the side effects of these agents to surrounding areas of the body.

According to market data from LSI, the outlook of the drug delivery devices market is favorable for a number of factors, including increased adoption and expanding indications for use. In 2020, global sales attributable to drug delivery devices were approximately $16.2M. 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 drug delivery devices market, as well as other medtech markets, visit LSI’s Medtech Pro platform.

Surgical Procedure Volumes – BPH Procedures in Australia

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 benign prostatic hyperplasia (BPH) procedures in Australia. There are multiple treatment options available to men with BPH, including transurethral resection of the prostate (TURP), energy-based ablative solutions, and implants to lift the prostate.

According to LSI’s Surgical Procedure Volumes database there were an estimated 19,000 BPH procedures performed in 2020 in Australia. BPH procedures were negatively impacted by the COVID-19 pandemic, with many procedures being cancelled or rescheduled while the impact of the pandemic was managed. As procedures have started to recover, LSI projects that BPH procedures will rebound in 2021 to 23,000 estimated procedures. Following this rebound, BPH procedure volumes will decline slightly as new treatment options reduce the number of reinterventions required for the treatment of symptomatic BPH.

Startup Spotlight

To see a Cala Health’s presentation at the LSI Emerging Medtech Summit, click here.

Learn more about Cala Health: https://calatrio.com/

Cala Health is a bioelectronic medtech company developing wearable neuromodulation therapies. The company’s mission is to transform the standard of care for chronic disease using personalized neurostimulation.

The company’s lead product, Cala Trio, is a novel, pharmaceutical-free device that is indicated for the relief of hand tremors in adults with essential tremor. The wrist-worn wearable device delivers transcutaneous electrical stimulation to the median and radial nerves of the wrist, providing on-demand relief of hand tremors. Therapy can be calibrated by a physician using data collected by on-board sensors in the device.

Figure 1: Cala Health's Cala Trio wearable

According to Cala Health, essential tremor is one of the most common movement disorders, affecting more than 7 million Americans alone. Beyond essential tremor, Cala Health is investigating new neuromodulation therapies for use in the fields of cardiology, neurology, and psychiatry.

Cala Health’s solution represents a new alternative therapy for patients suffering from essential tremor. While medications are available, they are not always effective. Deep brain stimulation (DBS) can be an effective treatment for essential tremor but requires invasive surgery to manage the disease.

Cala Health has raised over $71M in funding, with the most recent funding round being a Series C round which raised $50M in May 2019.

Life Science Intelligence is proud to announce that Biorez will be a presenting at the 2022 Emerging Medtech Summit in Dana Point, California.

New Haven, CT-based Biorez is committed to the development of solutions for healing soft tissue injuries. Each year, over 1 million tendon and ligament repair procedures are performed in the US. While good repair techniques have been established, current surgical materials for soft tissue repair have limitations which result in retear rates as high as 50%.

To address this limitation, Biorez’s has developed a biocomposite, bioinductive soft tissue scaffold to promote soft tissue healing. Biorez’s BioBrace implant features a highly porous type 1 collagen matrix that is reinforced with bioresorbable PLLA microfilaments. Once implanted, BioBrace provides supplemental strength to the repair site for up to 2 years before naturally resorbing.

Biorez announced that the company had received 510(k) clearance from the FDA in May 2021. The BioBrace implant is indicated for soft tissue repair procedures, including Achilles, bicep, quadricep, patellar, and rotator cuff repair surgery.

Figure 2: Biorez's BioBrace Implant

RenovoRx is a biopharmaceutical company developing a drug/device platform for the targeted delivery of chemotherapeutics. The company’s Trans-Arterial Micro-Perfusion (RenovoTAMP) platform is designed to isolate a tumor and deliver chemotherapy directly to the tumor’s location.

The RenovoTAMP platform is being developed to administer RenovoGem, intra-arterial gemcitabine that is delivered via the company’s proprietary RenovoCath delivery system. RenovoGem is being evaluated for multiple applications.

Figure 3: RenovoRx's development pipeline for its RenovoTAMP platform

On September 7^th, 2021, RenovoRx received 510(k) clearance from the FDA for its RenovoCath Delivery System. RenovoCath is a dual-balloon infusion catheter that is indicated for the isolation of blood flow and delivery of fluids to tumors in the peripheral vascular system. The device is also indicated for temporary vessel occlusions for other applications, including arteriography, chemotherapeutic drug infusion, and preoperative occlusion.

Thirteen days prior (August 25^th, 2021) to receiving clearance from the FDA, RenovoRx announced the pricing of its initial public offering (IPO). The company is now traded under the ticker symbol “RNXT”.

Boston Scientific was a lead investor in RenovoRx’s Series D round that closed in June 2018. Boston Scientific currently offers ablation and targeted drug delivery solutions for liver cancer.