The Origin of Mini C-arm Technology

By Lo I. Yin, Ph.D., and Larry Grossman This content of this white paper was originally co-authored by Lo I. Yin, Ph.D., and Larry Grossman to introduce Mini C-arm technology to the investment community prior to HealthMate, Inc.’s IPO in 1982.

The Origin of Mini C-arm Technology

It started in the late 1970s with Dr. Lo I. Yin, a NASA scientist who was working with Iodine-125 radioactive isotopes and Gen 2 night vision image intensifier technology at the Goddard Space Flight Center in Greenbelt, Maryland.

Yin decided that he could make a real time X-ray machine that was totally portable, weighing ten pounds and powered with two C-size batteries. The iodine-125 would produce low levels of radiation. The Gen 2 night vision image intensifier would receive the low-intensity radiation and amplify it to produce a real time X-ray image with 99% less radiation than existing fluoroscopy technology. Yin produced a prototype which he called the Low Intensity X-ray Imaging machine (LIXI). NASA patented the technology and, through the NASA technology transfer program, the agency licensed the patents to a new company, Lixi, Inc., located in Downers Grove, IL. Lixi, Inc. named the product the Lixiscope and became its manufacturer.

Lixi, Inc. signed an exclusive sales and marketing agreement with a new company, HealthMate, Inc., which was founded by Larry Grossman and located in Northbrook, Il. Grossman also served as HealthMate’s Chairman and Chief Executive Officer.

HealthMate needed to obtain a number of U.S. government agency approvals prior to marketing the Lixiscope, including from the Food and Drug Administration (FDA), which regulated medical equipment sales, approval to possess radioactive isotopes from the Nuclear Regulatory Commission (NRC), and a release from the U.S. Department of State through the Directorate of Defense Trade Controls (DDTC) to utilize Gen 2 night vision technology.

The government approvals were obtained, and HealthMate, Inc. began selling the Lixiscope. Early on, Mr. Grossman realized there were two major hurdles which caused barriers to entry into the medical market. The first was that the NRC required all users to take a radiation safety course to be able to obtain the radioactive isotope. HealthMate, Inc. was approved to give the course to the doctors, but it took four hours to complete.

Secondly, the DDTC required all users to complete a background check and sign a strict compliance agreement with the Department of State to possess Gen 2 night vision technology – technology which was proprietary to the US at the time. The Lixiscope was the only non-government use of the technology, which was primarily used for night vision googles, tank sights, rifle sights, and other military applications to be able to see at night. The government wanted to ensure that other countries could not obtain and reverse-engineer the technology. Doctors balked at both requirements, which greatly limited the sales and of the Lixiscope.

Another major obstacle stymied sales of the Lixiscope. Its Iodine-125 isotope had a 60-day half-life. When new, it had adequate radiation power to image from the elbow to the fingers. Within a few months, however, the isotope would decay to the point where it could only image the wrist and fingers. The isotope needed to be replaced every six months at a cost of more than $500 each time. This cost also substantially limited Lixiscope sales.

Grossman devised a method to overcome the obstacles. His plan was to invent a mobile fluoroscopy medical imaging technology that would not require a radioactive isotope.

Grossman’s concept used a small-powered X-ray tube with one-tenth of the radiation of existing X-ray machines to produce the radiation and a high-voltage controllable power supply to adjust the amount of radiation required. The new invention would replace the C-size battery with standard electrical current (120) voltage. Unlike the Lixiscope, this would allow the technology to be controllable. The user could adjust the current to be able to image any body part from the shoulder to the fingers and the knee to the toes. It would be a mobile low-intensity real-time fluoroscopy machine for extremity imaging – the first of its kind. The new device technology would also eliminate the need for an NRC license or the four-hour radiation safety course.

Grossman contacted Lo I. Yin, Ph.D., the NASA astrophysicist who invented the Lixiscope. He explained all of the obstacles and barrier to market entry the Lixiscope possessed. Grossman asked Dr. Yin to work with him to build a prototype of his concept. Lin formed a project group, QTR Consulting Group, to work with HealthMate, Inc. to build a prototype of Grossman’s invention. Other members of his team included Stephen Seltzer, a nuclear physicist working at the National Institutes of Health (NIH); Jacop Trombka, an astrophysicist working at NASA; and Arthur Ruitberg, an electrical engineer working as a senior power supply design engineer at NASA.

Grossman then met with the V.P. of the technology transfer department at NASA and negotiated an agreement for HealthMate, Inc. to have an exclusive patent license for the commercialization of the technology and to hire the QTR Consulting Group. NASA retained ownership of the patents and HealthMate, Inc. became the exclusive licensee. A prototype was built and named the ‘X-ray tube version of the Lixiscope’.

After Grossman received FDA approval to market the new technology, he renamed his invention the Mini C-arm. The device could image extremities with 99% less radiation than existing fluoroscopy devices, and Grossman named the new medical device product the Fluoroscan.