we recently ended invest The conference had a new take on our medical device introduction track: this year we decided to adapt it to remote patient monitoring and smart devices. The three judges — active investors from the traditional VC, corporate supplier and corporate payer VC fields — were drawn to the two presenters who decided to nominate a joint winner for the track.Alphabetically, they are located in San Francisco Brumio and St. Paul, Minnesota NxGenPort.
“At the highest level, we have selected these companies because their products have the potential to address a large unmet need, and the The founder articulates a sound business plan.” The meeting. “Furthermore, we like that these companies have a clear understanding of how reimbursement works and how their solutions fit into clinical workflows.”
Dipa Mehta, vice president of corporate venture capital and innovation at Advocate Aurora Health in Illinois, echoed: “Both companies also have a clear view of reimbursement for their technology in large markets (oncology and maternal health).”
The third judge, Tom Olenzak, managing director of Strategic Investments at Independent Blue Cross, pointed out the moderator’s skills in the comments.
“Both companies have impressive CEOs who can concisely define the company’s product and strategy,” Olenzak said.
The following are profiles of the two companies:
Brumio
Founded in 2016 to develop cuffless blood pressure monitors, the San Francisco startup has shifted its focus to managing high blood pressure in the market: pregnant women. Monitoring blood pressure is critical for expecting mothers, as complications of preeclampsia are high blood pressure and high levels of protein in the urine that can negatively affect other organs and can be harmful to both the mother and the fetus.
Co-founder and CEO Catherine Liao said in a recent online video interview that Blumio executives chose radar technology after analyzing the use of off-the-shelf sensors by other companies to develop cuffless displays.
“We chose radar because we know that radar has been used for vital signs sensing in hospital settings for a long time – usually by aiming the radar at the chest wall and taking vital signs like breathing rate and heart rate. We asked a question – Can you look at something more closely, in particular you can see the pulse of the arteries and give us something useful? Radar technology has evolved in this way over the past few decades to the point where radar systems are miniaturized Extent. They operate with great precision and can now delineate very, very small movements from large ones.
In determining the radar, Blumio was also able to take advantage of a technology jointly developed by Google and Infineon: a sensor chip that understands gestures and has Enter the Google Pixel 4 smartphone.
“So we looked at it and said, ‘It’s fine, but can we get health metrics out of it?'” recalls Liao. “So we worked with Infineon to explore the use of their radar [to measure blood pressure] And start actually hammering out the prototype. By the end of 2019, we had an initially validated working prototype. “
Last year, Blumio used the prototype system to study 120 subjects and published a Papers on System Accuracy. The goal now is to raise $8 million in Series A funding, having raised $4.5 million ($2.5 million of which is non-dilutive).
“In 2022, we are ready to take our prototype bench system and translate it into clinical form, and we can conduct more in-depth clinical studies to get FDA approval,” Liao said.
Appearance of the Blumio Cuffless Blood Pressure Device
The device will have a flexible base to be worn on the wrist to conform to the skin. The sensor can simply slide onto the device. The end user — in this case, a pregnant mother at risk for preeclampsia and who has prescribed a device made by Blumio — will wear it at night.
“Nocturnal hypertension is associated with preeclampsia,” Liao said.
Blumio won’t be the first company to bring a cuffless device to market. Liao said she is aware of three companies that have already obtained regulatory clearances in the US and/or Europe – BPro G2 wrist-worn device; this Biobeat Chest Monitor and Aktia Devices outside Switzerland. The first two are FDA-approved; Biobeat has a CE mark; and Aktiaa has a CE mark but is not FDA-approved.
Not ideal and not number one is not the end of the world. In fact, Liao believes in doing it right rather than being the first.
“We’re still in the early stages of competition because no cuffless device has really taken over the monitoring market — whether it’s inpatient, remote patient monitoring (chronic disease management, pregnancy, and other areas), or consumer-facing,” she asserted. “The bottom line is that there is no such thing as a ‘minimally viable medical device,’ it’s important that we take all the appropriate steps and not bring products to market with products that don’t work.”
Once the product is indeed approved, the reimbursement path appears to be clear, according to Liao. Today, RPM devices are more widely available, and there are currently two CPT codes available that provide up to $225 per month in reimbursement, assuming users are monitored for 9 to 10 months. Blumio’s wrist-worn device costs $69 a month.
If all goes according to plan, Liao expects commercialization to take place in late 2024 or early 2025 following fundraising and a larger trial that would help win FDA approval.
NxGenPort
Headquartered in St. Paul, Minnesota, NxGenPort is designed to provide remote patient monitoring for cancer patients undergoing chemotherapy. These patients have been implanted with a chemotherapy port, a small reservoir with a thin tube that is inserted into a large vein in the heart to give the patient medication. NxGenPort is adding optical sensors to turn such chemotherapy ports into smart devices that can provide the information oncologists need to decide whether a patient is sufficiently recovered for their next treatment.
“What we’re going to collect is a powerful package of data — the WBC counts down to five different white blood cells, ejection fraction, which is a measure of heart function, body temperature, oxygen levels, all of which combine to help oncologists In a recent Zoom interview, Cathy Skinner said:
Often, cancer patients complete one treatment, and if it doesn’t stop the disease from progressing, oncologists must decide, based on laboratory work, whether the patient is suitable for a different treatment or clinical trial. To do this, patients often have to go to a cancer clinic for blood tests. While NxGenPort doesn’t plan to assess the efficacy of any treatments, Skinner hopes to use remote patient monitoring to assess their health. Instead of sending patients to clinics, the company is developing a smart port that can be used for WBC information. In other words, she’s ruling out inconvenience.
“So we’re addressing an unmet need in cancer care, where cancer patients are not monitored during chemotherapy. In a sense, their blood counts and cell function are not tracked regularly, so treatment decisions are being made. or intervention, patients must go to a clinic for blood cell testing,” she said.
NxGenPort
In addition to optical sensors, the smart chemistry port utilizes machine learning.
“It’s hardware with optical sensors and software with machine learning that says, ‘That’s a red blood cell, that’s a white blood cell, that’s a red blood cell,'” she explained.
Ultimately, Skinner believes the AI being developed will even go beyond distinguishing between WBCs and RBCs. It will identify five different types of white blood cells in the body: granulocytes (neutrophils, eosinophils and basophils), monocytes and lymphocytes (T and B cells)
“We’re learning about the nuances of the difference between five white blood cells, specifically a type of cell called neutrophils, which is one of the definitive measures for oncologists to decide whether to go ahead with their next chemotherapy,” Skinner said. .
The same information about WBC can drive interventions of different nature. For example, if a patient’s blood work shows a decrease in WBCs, an oncologist can ask the patient for a blood transfusion or a growth factor Skinner. This can increase the WBC count.
Different types of WBC data is the point of difference from competitors like San Francisco CD (now called Veris Health), according to Skinner. Veris Health is also trying to improve the lives of cancer patients through remote monitoring. It’s developing an implantable vascular access device, but the company tracks physiological signs more broadly, such as body temperature and oxygen levels. It also has an accelerometer, Skinner said. Veris Health’s website and press release contain no further information on what specific data the Smart Vascular Access Port can collect.
Another Spain-based company, Leuko, is targeting cancer patients with a device it claims is the first non-invasive white blood cell monitoring device. The PointCheck will be a tabletop device into which patients can insert their fingers. Leuko’s website says the technology works by “illuminating light into the skin around the nail” and that the PointCheck can “image blood cells flowing through surface capillaries.” The company’s proprietary machine-learning algorithm can then determine whether “white blood cell levels are dangerously low.”
However, Skinner said having a desktop device may not be the safest way to collect health data on cancer patients.
“There are competitors in the market who are making devices that sit on someone’s coffee table and they have to stick their fingers into the device to get RBC and WBC. They don’t understand the nuances of the WBC difference as much as we do, but anyone’s grandchildren It’s possible to stick a finger into the device, so by implanting it in the body, we’re providing another level of accuracy in measuring the real people we’re collecting about the data,” Skinner asserted.
Founded in 2020, NxGenPort has been able to license a proprietary technology from the Mayo Clinic. In this way, NxGenPort is able to meet weekly with one of Mayo’s oncologists who can help them think through device development, data acquisition and workflow.
“In exchange for her expertise, Mayo took some equity in the company,” Skinner said.
According to Skinner, about 19 million people worldwide are diagnosed with cancer each year, and 10 percent of them have implanted chemotherapy ports. The market is large, and the potential for reimbursement is high if smart ports are FDA-approved.
There are about five different CPT codes that hospital systems can use to get reimbursed, Skinner said. NxGenPort devices cost $1,000 per device and include 12 months of remote monitoring data. In turn, hospitals will be able to charge $2,400 a year for the device based on available codes, Skinner claims.
She is currently looking to raise $1 million in a seed round, but eventually plans to raise a $12 million seed round next year, which will help gather the data needed to submit the hardware’s de novo 510(k) to the FDA General 510(k) for software and software that is part of the platform.
“We’re working to change the way treatment decisions are made and the way scheduling and clinical visits are made,” she said.
Image: Getty Images, Oat_Phawat
