Lumoptik, Inc.

Lumoptik gives sight to Haptic medical procedures. Light-based needle guidance platform technology with many high value medical uses. The company's first product is a needle guidance system for epidural procedures.

Spring Grove, IL, USA

One Liner

One Liner
Lumoptik gives sight to Haptic medical procedures. Light-based needle guidance platform technology with many high value medical uses. The company's first product is a needle guidance system for epidural procedures.

What Problem We are Solving

Current epidural standard of care is Loss of Resistance (LOR)--a Haptic procedure--done 100% by touch and feel (blind). It has been done this way for 100 years. Complications are common and costly to patients, providers and insurers. It is difficult to train new clinicians. Most people know someone who had issues due to an epidural.

About Us

About Us
Lumoptik, Inc is a medical device company that has developed the BrightPointTM Epidural System to assist physicians with needle placement during epidural procedures for childbirth, spine/back pain and surgical procedures such as knee and hip replacements. Over 11 million epidural procedures are performed in the US each year with over 30 million performed worldwide. The worldwide standard of practice is the Loss of Resistance (LOR) method which is performed free hand by physicians with no mechanical or electronic needle guidance. The BrightPointTM Epidural System is a low cost, easy to use device composed of a reusable handheld controller (resembles a smartphone) plus a single use, sterile fiber optic light channel designed to fit in the lumen of existing epidural needles. This is a razor (reusable handheld controller) and razor blade (disposable fiber optic) commercial design. 

Venture Highlights

Current Progress:
·         We have raised $1.4M of our $1.5M raise to conduct our clinical trial and submit our FDA DeNovo 510(k). This is a priced round with Series Seed   Preferred Equity at a $4.2M pre-money valuation. Tech Coast Angels (TCA) is our lead investor. The BOD has approved limited oversubscriptions for this round.
·         Research is done. The device has been tested in 4 Animal studies (pigs) and 1 human cadaver study which shows the technology works. This includes use by 10 anesthesiologists who had never seen the device before.
·         We did a pre-submission with the FDA and met with them 3 times. We have negotiated the DeNovo 510(k) requirements with the FDA, including a short clinical trial expected to last ~90 days. 
·         We have submitted our clinical trial application to the University Hospital Cleveland (UHC) Institutional Review Board (IRB) for review and anticipate approval the week of July 25. We anticipate we will treat our first patients in late August or early September at UHC.
·         We are manufacturing commercial use product for the FDA testing now.
·         The USPTO has issued an office action to us stating that they will allow our first patent claim. No patents granted to others which would interfere with our device. This means that any other company that sells a similar (me too) product will violate our patent.
·         Three separate marketing focus groups conducted with 21 anesthesiologists. Very positive response. Product developed based on physician feedback. Every single physician stated they would try the product when available.
·         Hospital For Special Surgery (HSS). We have a Letter of Intent (LOI) from HSS for a Clinical Collaboration Agreement to evaluate the BrightPointTM Epidural system and develop new platform technology products for orthopedic use. We are working on the final agreement and expect to close soon. The agreement also includes a $250K direct investment into Lumoptik. HSS is the #1 orthopedic hospital in the US.

Business Model

Business Model
 The business model is based on razors (the hand-held reusable controller) and razor blades (the disposable fiber optic). We are not manufacturing needles. The BrightPointTM Epidural device is used with existing FDA cleared needles & syringes (the clinicians do not need to change their current tools or work-flow to use the BrightPoint Epidural System). The hand-held controller has an estimated selling price of $1,000 and has a two-year warranty. The disposable, sterile fiber optic has an estimated selling price of $18 (per procedure). The device will be covered under current reimbursement codes for epidural accessories. 

Competitive Advantage

There are currently no viable competitors in the Epidural Market. We are essentially creating a new segment in the medical device field with our platform technology (multi-spectral reflectometers for guiding needles and probes). Lumoptik recently received our first patent allowance. Any other company that tries to enter the epidural market with a similar "me too" product will violate our patent. We also have a letter of intent from the Hospital for Special Surgery (HSS) in New York. HSS is the number 1 orthopedic hospital in the US. The proposed collaboration agreement with HSS includes working together to create new Lumoptik platform products in the pain management and orthopedic markets as well as a $250K direct investment.


Revenue To Date
Revenue YTD
Burn Rate

Go-To Market Strategy

Business Strategy
 : LUMOPTIK GO TO MARKET STRATEGY SUMMARY—this is dependent on how we develop a strategic relationship with a large commercial partner. During the FDA review period (while we are waiting) we will: • Publish results from the clinical trial at Univ Hosp in Cleveland right away on our website. o Extend the trial for a larger patient experience. • Start evaluation trials at 20 teaching hospitals and high-volume centers with Key Opinion Leaders (KOL’s). We have already spoken to: o University Hospital Cleveland o Cleveland clinic o Mount Sinai Hospital, NYC o Hospital for Special Surgery, NYC o University of MI o University of Wisconsin • The goal is to create a pipeline of published papers about the BrightPointTM Epidural System and set-up our first customers before we receive approval from the FDA • Once we have our clinical trial data--Contact distributors to set-up the supply chain prior to launch: o One pure national distributor (Medline, Henry Schein, etc.) 

Competitive Analysis

Competitive Analysys
There are currently no other competitor for light based needle guidance for epidural procedures. There is no FDA predicate device. We are performing a De novo 510(k) process with the FDA. 

Milestone Scientific is the only head on competitor (uses a pressure sensor, not light). They have ~$10M in sales (mainly dental product) with ~$70M valuation--we believe mainly based on their epidural product. Their product replaces LOR and has not gotten market traction since their FDA clearance in 2017. 

Competitor Website
Milestone Scientific


We are open to meeting up to grab a coffee, or just to chat. We would really enjoy your feedback and insight into our venture and would be happy to discuss anything that you are currently working on to see if we can be of service!



Name Amount
Amount Left $80,000.00
Amount Raised (This Round) $1,420,000.00
Amount Raise To Date $4.23M
Type of Raise Preferred Equity

Friends & Family
Seed Bridge



Business Stage

Business Stage

Business Type

Business Types



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