Summary: The FDA has cleared Compumedics’ Falcon HST device, which collects more data points than the company’s newly launched Somfit.
Key Takeaways:
- The Falcon HST is designed to complement Compumedics’ Somfit technology platform.
- The Falcon HST launched in Australia in October 2024, generating over $1 million in sales from 100+ units, with expectations to sell another 100-200 units by FY 2025.
- The company has built a dedicated U.S. sales team, initially selling the Somfit HST, with Falcon HST now added to its portfolio to accelerate market penetration.
- In Australia, Compumedics is exploring adjacent markets like cardiac disease, which could further expand revenue opportunities for the Falcon HST.
The US Food & Drug Administration (FDA) has cleared the Falcon HST device from Compumedics Ltd to be marketed in the United States, a significant strategic milestone for Compumedics USA home sleep testing (HST) market growth strategy.
The Falcon HST is designed to complement Compumedics’ Somfit technology platform, which has been gaining commercial traction in the United States’ HST market.
The Falcon HST is a fully integrated and connected end-to-end HST solution that captures more data points than the Somfit. According to Compumedics’ website, the device has two high-speed channels (EEG, EOG, or EMG), a high-speed auxiliary channel (AUX signal or EMG), a pressure-based airflow channel, a high-speed ECG channel with snap-to-snap leads, a thoracic inductive plethysmography belt, an abdominal inductive plethysmography belt, and an integrated position and accelerometer. The Falcon HST is compatible with reusable and disposable sensors. The software platform is Compumedics Profusion.
According to a press release, the Falcon HST is designed for fast and efficient patient self-setup without compromising signal quality, is scalable, and boosts convenience and ease of use for patients in their homes.
The Falcon HST was released in Australia in October 2024. So far, Compumedics has sold more than 100 Falcon HSTs (about $1 million in total revenues), with a further 100 to 200 Falcon HST devices expected to be sold by the end of fiscal year 2025. One of the biggest sleep therapeutic home care providers in Australia now uses Falcon HST exclusively, together with Compumedics Nexus 360 software as a service (SaaS) platform.
In Australia, Compumedics is testing the Falcon HST in markets adjacent to sleep, such as cardiac disease, which offers the company potentially significant markets to grow in.
In Australia, the Falcon HST Solution includes:
- Falcon HST device
- Falcon carry case
- Docking station for charging & data transfer
- Charging cable USB
- Falcon HST lead Kit
- 5x Falcon HST disposable kits
- wireless Bluetooth oximeter
- RIP inductive effort bands
- Profusion PSG 5 Falcon HST Edition Software Pack
- Two-year device warranty
According to Compumedics’ market research activities, the United States represents a potential new addressable market of between USD$100 million and USD$200 million a year in new and incremental SaaS revenues for Compumedics. (The revenue assumption is based on market research activities with existing HST providers in the US market, which included potential pricing for the Somfit and Falcon HST platforms, should they switch to Somfit and/or Falcon HST.) The revenue assumption is for the full market opportunity of about 4 million studies per year, using differing pricing points based on volumes of studies achieved.)
Compumedics is targeting to achieve between 10% and 30% of the addressable market over the next 24 months. Initial sales of Somfit in the last six months were approximately $1 million. The company has built a sales team in the United States focused on selling the Somfit HST platform, and the Falcon HST will be added to the product offering across the US sleep sales team now.
“Following FDA clearance for the Falcon HST device in the USA, Compumedics can further accelerate our HST commercialization strategy to capitalise on this high growth sleep market segment,” says David Burton, PhD, executive chairman and CEO of Compumedics, in a release. “The Falcon HST has already been on sale in the Australian market for six months now and we can take from our experience here that the product is highly regarded by both our existing and new customers, and this augurs well for the much larger USA market.”
