The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device technology. In 2024 alone,30 new devices were approved by the US Food and Drug Administration (FDA).
Wearable medical devices and the use of artificial intelligence in medical technology are two key trends in this sector. Moving forward, BCC Research projects that the global medical device industry will increase from US$810.4 billion in 2024 to US$1.3 trillion by 2029, expanding at a CAGR of 9.8 percent.
All data was compiled on January 14, 2025, using TradingView’s stock screener, and the medical device makers listed below had market caps between US$50 million and US$500 million at that time.
1. Delcath Systems (NASDAQ:DCTH)
Year-over-year gain: 202.86 percent
Market cap: US$405.43 million
Share price: US$12.69
Delcath Systems is a pharmaceutical and medical device company focused on “interventional oncology,” specifically in the treatment of primary and metastatic liver cancers. Delcath’s commercial product portfolio is focused on combining its Hepactic Delivery System (HDS) with the chemotherapeutic drug melphalan for ‘high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.’
The HDS is approved in the US and Europe under different commercial names and categories. In the US, it is marketed in combination with melphalan as the FDA-approved Hepzato Kit, which is considered a combination drug and device product. In Europe, the HDS is marketed as device-only under the name Chemostat Hepatic Delivery System for Melphalan and is regulated as a Class III medical device.
Delcath Systems’ share price got its first big boost in the second quarter of 2024, rising nearly 45 percent from US$5.56 on May 5 to US$8.04 on May 21, 2024, a period that included the publication of encouraging results from its FOCUS Study in metastatic uveal melanoma patients treated with the Hepzato Kit and its first quarter financials highlighting total revenues of US$3.1 million, up more than 416 percent over the same quarter in the previous year.
A series of positive study results released in late August sent shares in Delcath rising another 37 percent. This included an independent study conducted by the University Hospital of Leipzig, Germany, which shows the efficacy and safety of repeated chemosaturation treatments using Delcath’s Chemostat system for the treatment of patients with primary or secondary liver tumors.
On December 2, Delcath announced that it received FDA clearance for its investigational new Drug application for a Phase 2 clinical trial evaluating Hepzato in combination with standard of care for liver-dominant metastatic colorectal cancer. The clearance gives Delcath the authorization to initiate patient enrollment, which the company expects to begin in the second half of 2025. The news sent Delcath’s stock up to US$12.64 per share.
Shares in Delcath reached their highest yearly peak of US$12.79 on January 13, 2025, after the company shared outstanding preliminary fourth quarter and full-year total revenues of about US$15.1 million and US$37.2 million, respectively.
2. Sensus Healthcare (NASDAQ:SRTS)
Year-over-year gain: 147.76 percent
Market cap: US$108.01 million
Share price: US$6.59
Sensus Healthcare is a medical device company that delivers and develops non-invasive treatments for skin cancer and keloids. The company has developed a patient-centric treatment platform based on its superficial radiotherapy (SRT and IG-SRT) technology.
In early May 2024, Sensus Healthcare posted product sales milestones and robust first quarter financials that gave its share price a nearly 70 percent boost to US$6.42 on May 16. The company announced the sale of the first SRT-100 Vision (IG-SRT) system in Asia, followed by the commercial sale of the SRT-100 to a veterinary specialist in Israel, its first for veterinary use outside the United States. Lastly, Sensus reported Q1 2024 revenues of US$10.7 million, up from US$3.4 million in the prior-year quarter.
Sensus’ share price received its next big bump up in November after the company reported its Q3 financials, including revenues of US$8.8 million compared to US$3.9 million in the prior-year quarter. On November 20, the company’s stock reached its highest point of the past year at US$8.94 per share.
3. Pro-Dex (NASDAQ:PDEX)
Year-over-year gain: 118.55 percent
Market cap: US$146.02 million
Share price: US$44.80
Pro-Dex develops and manufactures battery-powered and electrical surgical instruments used in the orthopedic, spine, maxocranial facial and dental markets. Some of its customers include Smith & Nephew, the Lawrence Livermore National Laboratory, Medtronic (NYSE:MDT) and Arthrex.
Shares of Pro-Dex traded relatively sideways for much of the past year, with its biggest gains coming in the last four months. After the company announced its fiscal 2024 fourth quarter and full-year financial results in early September, its stock climbed nearly 42 percent to US$31.34 by October 1. Net sales for its Q4 ended June 30 increased by 41 percent year-over-year to US$15 million, while net sales for the fiscal year grew by 17 percent to US$53.8 million over the prior year.
Pro-Dex saw its stock price rally yet again in November, surging nearly 60 percent to US$49.55 per share on November 12. This latest upward momentum followed the company’s October 31 release of its fiscal 2025 first quarter financials. Net sales for the quarter ended September 30, 2024, increased 25 percent from the same quarter in the previous year to US$14.9 million.
4. AngioDynamics (NASDAQ:ANGO)
Year-over-year gain: 92.18 percent
Market cap: US$477.29 million
Share price: US$11.80
AngioDynamics is a global medical technology company that design, manufacturers and sells high-quality, minimally invasive medical devices. Its focus is on vascular access, surgery, peripheral vascular disease and oncology.
In mid-July, shares of AngioDynamics jumped 25 percent to US$7.51 following the release of its fiscal 2024 fourth quarter and full-year financials.
“Within our Mechanical Thrombectomy segment, we achieved key milestones by receiving both FDA 510(k) clearance and CE Marking for AlphaVac in the treatment of pulmonary embolism,” Jim Clemmer, President and CEO of AngioDynamics, stated. “These indications open up multiple large, fast-growing markets, and helped to drive a more than 68% sequential increase in AlphaVac revenue during the fourth quarter.”
AngioDynamics received FDA 510(k) clearance for its NanoKnife System for prostate tissue ablation on December 9, sparking a 31 percent rally that brought the share price to US$9.33 on December 16.
Shares in AngioDynamics hit their highest yearly peak of US$12.94 on January 8 following the release of the company’s fiscal 2025 second quarter financials. Net sales for the quarter came in at US$73 million, up 9.2 percent compared to the prior-year quarter.
5. KORU Medical Systems (NASDAQ:KRMD)
Year-over-year gain: 85.84 percent
Market cap: US$186.56 million
Share price: US$4.07
KORU Medical Systems develops and manufactures medical devices and supplies in the United States and internationally, with a focus in mechanical infusion products. Its Freedom Syringe Infusion System first received FDA clearance in 1994. Based on this system, its primary products include the FREEDOM60 and FreedomEdge Syringe Infusion Drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets.
Shares in KORU Medical made their biggest price gains in the last few months of 2024, rising more than 67 percent from the end of October to a yearly peak of US$4.40 per share on December 12.
On October 31, KORU Medical released positive data that it had presented days prior at the Partnership Opportunities in Drug Delivery Conference in Boston, Massachusetts. The data demonstrates nursing preference for use of the KORU FreedomEdge Infusion System over manual syringe administration for subcutaneous oncology infusion.
In mid-November, the company shared its third quarter 2024 financial results, which included net revenues of US$8.2 million, up 17 percent over the prior year period.
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
