Caelum Diagnostic Solutions

My name is Dr. Rachel Wellner. I am a breast surgical oncologist and founder/CEO of Caelum Diagnostic Solutions, Inc. (CDS) We are a C-Corp founded in Delaware and operating out of California. Caelum is a very passionate company whose mission is somewhat groundbreaking. In the cancer space, more accurately put the diagnostic biopsy space in general, patients undergo diagnostic, semi-invasive biopsy procedures every day to rule out the presence of malignant cells in various organs of their bodies. Once the biopsy procedure is complete, removed tissue is sent for conventional histopathologic diagnosis, a process that, on average, takes 2 business days, but in practice can take weeks. Some studies have even shown that the time it takes from noticing a suspicious lesion to biopsy results ranges from 24-48 days and 72 days until definitive treatment. 

 

At CDS, we find this wait for biopsy results to be unacceptable and have developed a technology to render a biopsy evaluation in 10 minutes with 94-99% accuracy (on par with traditional pathology), while the patient is still on the procedure table. This disruptive technology is guaranteed to speed up treatment, load up costs savings and benefits for the customers (hospitals, ambulatory centers, free standing interventional radiologists, and free-standing offices where biopsies and procedures like Moh’s are performed). 

 

We’ve performed our first Proof of Concept study with highly favorable results and are ready to move on to developing a prototype and begin clinical trials. In addition, there appears to be an FDA-approved predicate that doesn’t compete in this space, allowing us to qualify for a 510K or de novo, which would accelerate the FDA pathway and cut costs associated with the submission significantly. 

 

Furthermore, we have a world-class team with collectively over 100 years’ of experience in start-ups, biotech, bio-engineering, laser physics, clinical medicine and oncology, pathology, and finance, to name a few of our skills. 

 

The anxiety and life stress associated with waiting for biopsy results is practically indescribable. In my twenty years of practice, I found that the fears that patients would express to me, their families, friends, employers, and the like significantly interfered with their lives. We are currently conducting preliminary market research, and have received an MOU from a national KOL in addition to positive feedback from other clinicians. We  also submitted our final (initial) IP in December (we plan to submit multiple patents). We are currently focused on the construction of our prototype with clinical testing on our proprietary device.    

 

This massive problem is what compelled us at CDS to find a solution now. Frankly, medical centers can’t afford the problem of waiting for conventional pathology and require a solution like ours immediately. We hope you will consider helping to fund this highly worthwhile and game-changing endeavor. 

 

I look forward to hearing from you. 

Sincerely, 

Rachel B. Wellner, MD MPH FACS