Company Overview
HeatSYNC™ is a novel injectable gel to increase the effectiveness of IGTA. Theromics is
developing HeatSYNC, an injectable gel that augments electromagnetic energy to enhance
thermal ablation performance. It is considered a “medical device/biologic” by the FDA. It has
the viscosity of honey and is designed to amplify the heat generated from the energy
applicators to kill diseased cells more effectively during IGTA procedures. The proprietary
gel is formulated from a human polymer protein and biological agents that create a more
favorable environment in human tissue for heat transfer, making the ablation zone more
enormous and spherical. The gel is delivered using a needle, laparoscope, or bronchoscope
as part of the ablation procedure before energizing the applicator. The doctor places
HeatSYNC near the treatment area, and the ablation generator is activated. The gel
absorbs and strengthens the energy and refocuses the heat to the treatment area,
acting as a virtual applicator. The augmentation is controllable and customizable, creating
better ablation volumes and safety margins in a shorter time. HeatSYNC can be prepositioned
easily under image guidance and remains stationary throughout the ablation
procedure. In addition, HeatSYNC is formulated to “shut off” via denaturation so as not to
overheat healthy, non-tumor tissue. This ingenious fail-safe system can be adjusted
depending on ablation modality and protects patients from over-ablation while providing
more precise tumor targeting. Multiple overlapping ablations and needle repositioning are
the most time-consuming part of the IGTA procedure. Adding HeatSYNC decreases the
need for overlaps and repositioning, saving significant operating room costs. In 50% of
ablations, the facility must spend an additional ~$6000 due to using more than one
disposable applicator, while Medicare only reimburses a total outpatient payment of $8125.
HeatSYNC behaves like a "virtual" applicator, reducing the need for multiple probe
procedures and saving thousands of dollars in most ablations. In addition, there is no need
for additional capital equipment expenditures, minimizing any cost associated with therapy
initiation and training costs. Combining better outcomes, shorter procedure times, and
fewer expensive applicators used in IGTA provides multiple synergistic benefits for the
healthcare system. Our customer inquiry determined a selling price (ASP) of $1250 by
offering applicable price range assumptions and comparable technologies to our customer
base for price discovery. About 65% of respondents would pay between $500 - $1000 per
dose, and an additional 15% noted they would pay at least one-half of the cost of an
ablation electrode, which averages $2500. The cost of goods sold (COGS) for HeatSYNC is
approximately $150 as the constituents are inexpensive (polymer protein at $50 per dose,
chaotropic agents at $10 per dose) and readily accessible. Manufacturing costs, including
packaging, sterilization, and quality control, are $80 per dose as the manufacturing process
is straightforward.
Financial Info
Raising
$2M
Meet the Team
Ron Murphy
CEO
Theromics Inc
Theromics has developed a biopolymer that makes thermal ablation and drug delivery more
effective cancer treatments.
Problem
Interventional oncology is the new 4th pillar of cancer care, and the two modalities for
IO is Image Guided Thermal Ablation (IGTA) and immunotherapy. Theromics has
developed the first bio-polymer gel to make Image-Guided Thermal Ablation (IGTA) a more
effective cancer treatment by augmenting thermal energy transfer in human tissue. Image-
Guided Thermal Ablation (IGTA) is a localized, non-surgical method to treat tumors by
inserting needle-like applicators into the tumor under imaging guidance and destroying the
cancerous tissue by applying intense heat. Although the procedure is widely used,
accessible to most patients who need it, and safe and well-tolerated, it has a 30% local
recurrence rate due to incomplete ablations. The challenge is to kill all the tumor cells, and
only tumor cells, with minimal damage to surrounding normal tissue. HeatSYNC gel
increases IGTA effectiveness by substantially increasing the electrical conductivity of living
tissue. HeatSYNC can be combined with any standard microwave, radiofrequency, or
irreversible electroporation device and will elevate IGTA to a front-line therapy for treating
solid tumors. According to GLOBOCAN, 20M new cancer cases are diagnosed every year.
Close to one-third of these cancers occur in the liver, lung, or breast. Advancements in
technology and an aging population that are too sick for surgery have created a tremendous
demand for minimally invasive therapies, including Image-Guided Thermal Ablation (IGTA).
Despite these advantages, thermal ablation has limitations as a cancer treatment due to a
30% local tumor recurrence rate in some organs. Often, the ablation does not neutralize the
entire tumor because it misses a small part of it. Also, “heat sinks,” which are large blood
vessels, rob the heat directed from the applicator, lowering the treatment temperature and
making the ablation less effective. Presently, clinicians attempt to mitigate incomplete
ablations intra-procedurally. Repositioning applicators to cover larger areas is prevalent but
time-consuming. In addition, doctors often must use an “overlapping” strategy to ablate
larger lesions, which is technically challenging. These technical challenges have given rise
to expensive multiple-probe procedures. Adding additional applicators occur in over 50% of
ablation procedures and adds $2000 to $6000 per procedure. In addition to augmenting
ablation, drugs can be combined with the gel to deliver the agents directly into the area of
diseased tissue. The gel is a protein and can accept any medicine, immunotherapy, or
agent that can withstand ablation heat. Combining the drug with the gel will mean that
lower doses will be used, and the adverse side effects, which include cardiotoxicity and an
overactivated immune system (inflammation), can be avoided. This therapy called "TACT -
Thermally Activated Combination Therapy" is proprietary to Theromics. The company is
initiating studies in collaboration with and paid for by a major pharma company to develop
this platform further.
Highlights
We have multiple publications in peer-reviewed journals and won the Best Abstract at the
Asian Tumor Ablation Conference 2022.
The company is also a winner in the M2D2 Challenge Cup, M2D2 IMPACT cohort 4, has
received NSF SBIR Ph I funding, and anticipates $1.5M in NSF Ph. II grant funding in
Q2:23.
The company has also presented abstracts at the Society for Interventional Radiology
conference in 2022 and 2023 and the Society Of Interventional Radiology Annual Meeting
in 2022 and 2023.
Go-To-Market Strategy
With newly developed technology like HeatSYNC, the initial “touchpoints” are the clinicians
and the hospital or institution’s “value analysis committee” (VAC), while the purchasing office
remains the actual customer. However, device companies can often avoid the VAC if they
can show a benefit to the patient and if the cost is like the other disposables being used with
that capital equipment. Theromics’ low cost and efficacy position the company’s sales team
to address the VAC goal of balancing quality care with cost efficiencies.
Multiple overlapping ablations and needle repositioning are the most time-consuming part of
the IGTA procedure. Adding HeatSYNC decreases the need for overlaps and repositioning,
saving significant operating room costs. In 50% of ablations, the facility must spend an
additional ~$6000 due to using more than one disposable applicator, while Medicare only
reimburses a total outpatient payment of $8125. HeatSYNC behaves like a "virtual."
applicator, reducing the need for multiple probe procedures and saving thousands of dollars
in most ablations. In addition, there is no need for additional capital equipment
expenditures, minimizing any cost associated with therapy initiation and training costs.
Combining better outcomes, shorter procedure times, and fewer expensive applicators
used in IGTA provides multiple synergistic benefits for the healthcare system.
When addressing the hospital VAC and purchasing office as a customer, there can be
hurdles to overcome. There can be hurdles to overcome when addressing the hospital VAC and purchasing office as a customer. Although there is no standard procedure for how a VAC operates,
there may be limited vendor-to-VAC communication. The Theromics sales team will work
diligently to cultivate relationships with clinicians and inside the large academic VACs and
purchasing offices to educate them on the value of HeatSYNC gel. We can review and
contribute to documents the physician submits to the VAC. Also, we help prepare the
physician before the meeting, using a VAC kit, to defend their request in front of the
committee comprehensively. In addition, we will work directly with the VAC to provide
clinical data, FDA approvals, financial analysis, and other requests.
Our customer inquiry determined a selling price (ASP) of $1250 by offering the applicable price
range assumptions and comparable technologies to our customer base for price discovery.
About 65% of respondents would pay between $500 - $1000 per dose, and an additional
15% noted they would pay at least one-half of the cost of an ablation electrode, which
averages $2500.
The cost of goods sold (COGS) for HeatSYNC is approximately $150 as the constituents
are inexpensive (polymer protein at $50 per dose, chaotropic agents at $10 per dose) and
readily accessible. Manufacturing costs, including packaging, sterilization, and quality
control, are $80 per dose as the manufacturing process is straightforward.
What Makes Us Special
Clinicians have tried various approaches to alleviate the effects of heat sinks, improper
electrode placement, and negative safety margins in thermal ablation procedures. They
have incorporated Intraprocedural techniques such as creating multiple overlapping ablation
zones, repeated repositioning of electrodes, or using more than one electrode. These
approaches are costly and time-consuming but indirectly compete with HeatSYNC gel.
With the exclusion of saline solution, the concept of a "thermal accelerant" is brand new
and novel and nothing like it is currently on the market. Likewise, except for HeatSYNC gel, there has
been little innovation in ablation technology outside of "building a better mousetrap” systems
by Medtronic and Johnson and Johnson. One exception could be the CAS-One treatment
planning software integrated with robotics (Cascination AG) to ablate lesions accurately.
However, the CAS-One product has a steep development ramp, and its US uptake has
been limited. In addition, all these technologies are costly and limited to types of
treatable tumors and energy sources. In contrast, HeatSYNC gel is an inexpensive
alternative technology that combines the intended effects of these technologies in a "one
size fits all" adjuvant to current systems and applicators.
In the next five years, Theromics anticipates further efforts by the industry to optimize its legacy
amplifier designs by making them more focused and unidirectional. Also, AI-integrated
robotics may target a lesion more precisely in the future. However, HeatSYNC can be easily
used with robotic technology, probe placement software, and new amplifier designs to
improve ablation outcomes.