Prostate cancerFocal therapyDevice in development
Focal Medical is an early-stage medical device company developing a minimally invasive, energy-based system for mapping prostate tissue and delivering focal ablation to a targeted region within the gland.
Investigational device in development. Not cleared or approved by any regulatory authority, and not available for sale or clinical use.
Illustrative concept diagram. Not a clinical image, and not representative of system output.
Early-stage, clinically focused
One indication and one defined clinical problem, rather than a platform looking for an application.
Designed for targeted treatment
Built around the region of the gland that carries the disease, instead of the gland as a whole.
Built for precision
Mapping and delivery developed together, so the plan and the treatment share one frame of reference.
Overview
The disease is frequently confined to one part of the prostate. The treatments most widely used against it are not.
Prostate cancer behaves unlike most solid tumours. A substantial share of the disease found through screening grows slowly, and a meaningful proportion of it would never go on to cause symptoms or shorten a man's life. For decades, though, the practical choice put in front of him has been close to binary.
On one side sits active surveillance. The gland is monitored with repeat testing, imaging and biopsy, and treatment is withheld unless there is evidence of progression. It spares men a procedure they may never need. It also asks them to live alongside an untreated cancer and a recurring schedule of appointments, scans and needles.
On the other sits radical treatment: remove the prostate, or irradiate it. This addresses the disease decisively, and it treats a great deal of tissue that was never involved. Because the nerve bundles and the sphincter responsible for erectile function and urinary continence sit immediately against the gland, whole-gland treatment carries well-documented rates of incontinence and sexual dysfunction. Those consequences are not rare, and men live with them for years.
What has changed is what clinicians can see before they decide. Multiparametric MRI and image-fusion biopsy now routinely localise clinically significant disease to a region of the prostate rather than to the organ as a whole. The information required to treat more selectively increasingly exists by the time the treatment decision is made.
Focal therapy is the clinical response to that gap. Treat the part of the gland that carries significant disease, preserve the surrounding tissue and the structures around it, and keep surgery and radiation available should they be needed later. The rationale is widely discussed in the urological literature. The instruments used to deliver it have largely been adapted from tools designed for something else.
We are building for that setting specifically, and building the path through it rather than a single instrument along the way.
The system under development is designed so that the step which establishes where the disease sits and the step which treats it belong to the same workflow: one set of coordinates, one plan, one procedure. The intent is to remove the translation a clinician currently performs in their head between a scan taken weeks ago and the anatomy in front of them today, and to make the boundary of what gets treated an explicit decision rather than an inference.
That is a design philosophy, not a result. The system is in development and its performance has not been established. What we can set out today is the problem we have chosen, the approach we are taking to it, and the evidence we intend to generate.
Technology
Described in plain language, without the engineering vocabulary. Everything below sets out design intent for a system that is still in development.
A minimally invasive probe is positioned within the treatment area and used to build a spatial picture of the gland: where its boundaries are, where the target region sits, and where the structures worth preserving lie in relation to it. The result is a working map tied to the patient’s anatomy at the moment of treatment, rather than to a scan taken weeks earlier.
Treatment is delivered by applying controlled energy to a defined volume of tissue so that the tissue is destroyed where it sits. Nothing is cut out and nothing is removed. The energy is directed at the region identified during mapping, and the treatment volume is shaped to that region rather than to the gland as a whole.
Between those two steps sits the part that makes them one system. The map defines the target, the plan defines the delivery required to cover it, and the control layer is designed to hold delivery inside the planned boundary while treatment is under way, so that the edge of the treatment is a decision rather than an estimate.
The system is designed to reach the treatment area without open surgery, using an approach intended to sit inside established urological practice. The aim is a procedure that fits the rooms, equipment and teams that already exist, rather than one that asks a department to rebuild itself around a new device.
Reach the treatment area through a minimally invasive route, without an open incision.
Build a spatial picture of the gland, the target region and the structures worth preserving.
Define the treatment volume and the energy delivery required to cover it.
Apply controlled energy inside the planned boundary, with delivery monitored throughout.
Review what was delivered against what was planned before the procedure is closed.
Four consequences of designing the mapping step and the treatment step as a single system rather than as two instruments used in sequence.
The plan and the treatment share one frame of reference.
Nothing has to be mentally re-registered from an image taken weeks ago onto the anatomy on the table today.
The treated volume is defined before any energy is delivered.
The boundary of treatment becomes an explicit, reviewable decision instead of something inferred during the procedure.
Tissue outside the target is left alone by design.
Preserving the rest of the gland is the purpose of the approach, not a fortunate side effect of it.
It is built for the room it would be used in.
Designed around the workflow, staffing and equipment of a urological procedural suite rather than a research setting.
Clinical Focus
Everything in this section describes design intent and planned work. None of it describes a cleared indication, an authorised use, or a demonstrated clinical outcome.
The use the system is being developed for. This is a description of design intent, not a regulatory indication for use.
The objectives the design is measured against internally. These are goals rather than demonstrated results, and whether the system meets them is a question for clinical investigation to answer.
Focal Medical’s system is investigational. It is in development, it has not been cleared or approved by the United States Food and Drug Administration, it has not received a CE marking, and it holds no marketing authorisation in any other jurisdiction. It is not available for sale and it is not available for clinical use outside an appropriately authorised investigation. Nothing on this site should be read as a claim of safety, effectiveness or performance.
Our programme is structured to generate evidence in sequence: bench testing to characterise energy delivery and the boundary of the treated volume; preclinical work to assess the approach in relevant models; and clinical investigation carried out under the applicable regulatory pathway, with ethics committee or institutional review board oversight and informed consent.
We intend to report results through peer-reviewed publication and scientific meetings as they become available, including results that do not support our hypotheses. Detailed technical, preclinical and regulatory material is shared with clinical collaborators, prospective investors and partners under confidentiality.
If you are a clinician or researcher with a view on study design, endpoint selection, patient selection criteria or site participation, that conversation is more useful to us early than late. The contact form below reaches the team directly.
This site is informational and not intended for medical advice. It does not describe a treatment that is available to patients. If you have been diagnosed with prostate cancer, or you are concerned about your prostate health, please speak with a qualified healthcare professional about the options open to you.
Partnership
We are early, which means the decisions that will determine whether this works are still open. That is exactly the point at which outside expertise changes the outcome rather than confirming it.
Study design, endpoint selection, patient selection criteria, and a frank view of where the approach is weakest. We would rather hear the objection now than after the protocol is written.
Access to models, test facilities and comparative methods that characterise energy delivery and the treated boundary in a way reviewers and clinicians will find credible.
Early-stage capital, and syndicate partners who understand medical device timelines, regulatory milestones and the capital profile that comes with them.
Organisations active in urology, diagnostic imaging or energy-based therapy, where a shared roadmap is worth considerably more than a licence.
Pathway strategy, quality management system build-out, and the experience of having taken a device of comparable classification through review before.
Specialists in energy delivery hardware, probe design, sterilisation, biocompatibility and contract manufacture at development volumes.
The overview deck is a short, plain-language summary of the clinical problem, the approach we are taking, the state of the programme and what we are working towards. We send it on request, without requiring a call first.
Detailed technical, preclinical and regulatory material follows under confidentiality, after an introductory conversation. If you tell us which of the areas above you are interested in, we will send the material that is actually relevant to it rather than everything we have.
Contact
Tell us who you are and what you would like to see. Messages reach the founding team directly rather than a shared inbox.
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